Regeneron is a leading biotechnology company that focuses on discovering, developing, and commercialising innovative medicines for serious medical conditions. Their work spans across various therapeutic areas, including oncology, ophthalmology, immunology, and infectious diseases. Regeneron's ultimate goal is to bring groundbreaking therapies to patients who need them, transforming the way diseases are treated and improving quality of life. The company is driven by a commitment to science, innovation, and the relentless pursuit of solutions to some of the most challenging health issues in the world today.


Science & Healthcare

Regeneron 

You should have a BS in Engineering, 2-5 years of relevant experience, knowledge of antibody manufacturing and chromatography, strong organizational skills, and proficiency in Microsoft Suite.

You will support process transfer, analyze R&D data, evaluate product risks, draft control documents, coordinate with stakeholders, and present findings in cross-functional meetings.

East Greenbush

Regeneron is looking for an Process Controls and Validation Engineer for our Process Sciences Development and Lifecycle Management Team. This is a non-lab based position. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product, done in part through in-process controls applied to our production processes. This position will be responsible for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory Departments. This position will also be responsible for developing, managing, and maintaining the IPC program for each product. In this fast-paced environment with a strong pipeline, associates in Process Sciences have an opportunity to work on various aspects of the process and business. 
 As a Process Controls &amp; Validation Engineer, a typical day might include the following: 
 Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development team 
 Analyzing R&amp;D, late-stage characterization studies, and historical manufacturing data to support process control programs. 
 Evaluating product and process risks and providing justification for implementing process controls or for making updates to existing process control programs. 
 Assessing criticality of product attributes to support the creation of product specifications. 
 Drafting process control documents, including Process Control Strategy documents, In-Process Control (IPC) Development Reports, and Process Performance Monitoring Plans, including setting relevant limits using appropriate scientific rationale or statistical analysis, where appropriate. 
 Coordinating with stakeholders to obtain additional data as needed to support the creation, updates, and changes to process control programs. 
 Presenting process control program structure, rationale, and methodologies during cross-functional meetings and to senior leadership when required. 
 Participating in brainstorming sessions where we look for ways to continuously improve our Process Control Development and Lifecycle Management processes. 
 
 This role might be for you if you:
 Understand antibody manufacturing processes. You have in-depth knowledge of liquid chromatography; experience in analytical chemistry, pharmaceutical sciences and protein characterization using a variety of analytical tools for solution-based analyses. 
 Enjoy working in a fast-paced environment. 
 You are detail-oriented, quality-driven, and well organized. 
 You have the innate ability to balance multiple projects and prioritize and execute them independently while excelling at keeping all impacted parties well advised. 
 Can take on new and sometimes ambiguous challenges, learning quickly. 
 Detail-oriented, good interpersonal and effective technical writing and verbal communication skills. 
 You enjoy working in a team environment but can also take ownership of multi-faceted projects and technical reports. 
 Can develop and drive scientific and/or business-related improvement ideas. 
 Have a solid understanding of Microsoft Suite (Word, Excel, Powerpoint). 
 To be considered for the Process Controls and Validation Engineer you must be willing and able to work Monday- Friday 8am-4:30pm. You must have a BS in Engineering; Chemical Engineering or Biochemical engineering is preferred .For various levels you must have the following: 
 Process Controls &amp; Validation Engineer: 2+ years of relevant experience 
 Sr. Process Controls &amp; Validation Engineer: 5+ years of relevant experience 
 Experience with downstream chromatography and protein purification is preferred. Understanding of statics and statical analysis is preferred. Level is determined based on qualifications relevant to the role. 
 #LI-MB1 
 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
 For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
 Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. 
 Salary Range (annually) $58,480.40 - $106,300.00

Regeneron is looking for an Process Controls and Validation Engineer for our Process Sciences Development and Lifecycle Management Team. This is a non-lab based position. Regeneron has successfully commercialized numerous products. Gaining approval from regulatory agencies is dependent on demonstrating that our processes are robust, consistent, and produce quality product, done in part through in-process controls applied to our production processes. This position will be responsible for writing and reviewing documents that support Manufacturing, Quality Control, and CMC Regulatory Departments. This position will also be responsible for developing, managing, and maintaining the IPC program for each product. In this fast-paced environment with a strong pipeline, associates in Process Sciences have an opportunity to work on various aspects of the process and business. 
As a Process Controls & Validation Engineer, a typical day might include the following: 
Working with a multi-functional team to support technology transfer and scale-up of processes from Regeneron’s process development team 
Analyzing R&D, late-stage characterization studies, and historical manufacturing data to support process control programs. 
Evaluating product and process risks and providing justification for implementing process controls or for making updates to existing process control programs. 
Assessing criticality of product attributes to support the creation of product specifications. 
Drafting process control documents, including Process Control Strategy documents, In-Process Control (IPC) Development Reports, and Process Performance Monitoring Plans, including setting relevant limits using appropriate scientific rationale or statistical analysis, where appropriate. 
Coordinating with stakeholders to obtain additional data as needed to support the creation, updates, and changes to process control programs. 
Presenting process control program structure, rationale, and methodologies during cross-functional meetings and to senior leadership when required. 
Participating in brainstorming sessions where we look for ways to continuously improve our Process Control Development and Lifecycle Management processes. 

 This role might be for you if you:
 Understand antibody manufacturing processes. You have in-depth knowledge of liquid chromatography; experience in analytical chemistry, pharmaceutical sciences and protein characterization using a variety of analytical tools for solution-based analyses. 
Enjoy working in a fast-paced environment. 
You are detail-oriented, quality-driven, and well organized. 
You have the innate ability to balance multiple projects and prioritize and execute them independently while excelling at keeping all impacted parties well advised. 
Can take on new and sometimes ambiguous challenges, learning quickly. 
Detail-oriented, good interpersonal and effective technical writing and verbal communication skills. 
You enjoy working in a team environment but can also take ownership of multi-faceted projects and technical reports. 
Can develop and drive scientific and/or business-related improvement ideas. 
Have a solid understanding of Microsoft Suite (Word, Excel, Powerpoint). 
To be considered for the Process Controls and Validation Engineer you must be willing and able to work Monday- Friday 8am-4:30pm. You must have a BS in Engineering; Chemical Engineering or Biochemical engineering is preferred .For various levels you must have the following: 
Process Controls & Validation Engineer: 2+ years of relevant experience 
Sr. Process Controls & Validation Engineer: 5+ years of relevant experience 
Experience with downstream chromatography and protein purification is preferred. Understanding of statics and statical analysis is preferred. Level is determined based on qualifications relevant to the role. 
#LI-MB1 
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. 
Salary Range (annually) $58,480.40 - $106,300.00

Process Controls Engineer - Regeneron 

Regeneron Pharmaceuticals Inc.

Process Controls Engineer

You need a relevant bachelor's degree, procurement experience in Pharma/BioPharma, strong negotiation skills, market insights, and preferred knowledge of sourcing tools and managing associates.

You will define and implement procurement strategies, lead negotiations, ensure compliance, manage supplier relationships, and drive cost savings aligned with corporate priorities.

Dublin

The Senior Manager Global Procurement-R&amp;D will be responsible to support and assist in the development and implementation of the Category Management strategy by gathering and anticipating business unit supply needs and specifications for projects. Must demonstrate capability to proactively handle a supply base and increase value, minimize risk, and ensure quality &amp; cost efficiency by working collaboratively with business unit. 
 
 A typical day might look like:
 Accountable for supporting the definition and implementation of the Global Clinical Category strategies to serve global and regional business needs as assigned. 
 
 Working closely with partners to handle discussions and align category priorities with Procurement management and partners. 
 
 Leading negotiations, supplier management activities, and customer engagement activities 
 
 Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. 
 
 Representing Global Procurement by participating in organizational decisions with critical short and long-term impact on the success, efficiency, growth, and results of Global Procurement. 
 
 Demonstrating knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the Global Procurement organization and demonstrating this knowledge to drive improvements within Regeneron, aligned with corporate priorities. 
 
 Leading category activities to ensure compliance with appropriate GxPs and other applicable regulations, as applicable. 
 
 Negotiating contract terms and conditions in consultation with Law department aligned with Regeneron’s priorities and business requirements. 
 
 This role might be for you if you have:
 A bachelor's degree in a relevant field of study plus relevant, progressive experience in procurement, including experience in Pharma/BioPharma. 
 
 Experience effectively leading category processes, and suppliers across a breadth of categories 
 
 Successfully worked effectively with cross-functional teams to drive results through effective sourcing, negotiations and contracting 
 
 Insight and knowledge regarding rates, unit costs, and costing structures to enable efficient negotiations. 
 
 Used external data sources, market information, and supplier engagement to constantly improve Regeneron’s knowledge of supply market dynamics. 
 
 Experience operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement. 
 
 Proven success supporting global supply market evaluation processes using all available market intelligence, risk, compliance, and financial assessment tools. 
 
 Experience managing associate level professionals preferred 
 
 Working knowledge with sourcing contracting tools, ERP’s, and eRFx systems preferred. (Oracle, Zycus, Ariba, Other) 
 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
 For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
 Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

The Senior Manager Global Procurement-R&D will be responsible to support and assist in the development and implementation of the Category Management strategy by gathering and anticipating business unit supply needs and specifications for projects. Must demonstrate capability to proactively handle a supply base and increase value, minimize risk, and ensure quality & cost efficiency by working collaboratively with business unit. 

 A typical day might look like:
 Accountable for supporting the definition and implementation of the Global Clinical Category strategies to serve global and regional business needs as assigned. 

 Working closely with partners to handle discussions and align category priorities with Procurement management and partners. 

 Leading negotiations, supplier management activities, and customer engagement activities 

 Taking direction to drive value in terms of cost savings, cash flow improvement, and other efficiency savings from category management activities. 

 Representing Global Procurement by participating in organizational decisions with critical short and long-term impact on the success, efficiency, growth, and results of Global Procurement. 

 Demonstrating knowledge of efficient global procurement organizations and processes within the biopharmaceutical industry to support the growth and evolution of the Global Procurement organization and demonstrating this knowledge to drive improvements within Regeneron, aligned with corporate priorities. 

 Leading category activities to ensure compliance with appropriate GxPs and other applicable regulations, as applicable. 

 Negotiating contract terms and conditions in consultation with Law department aligned with Regeneron’s priorities and business requirements. 

 This role might be for you if you have:
 A bachelor's degree in a relevant field of study plus relevant, progressive experience in procurement, including experience in Pharma/BioPharma. 

 Experience effectively leading category processes, and suppliers across a breadth of categories 

 Successfully worked effectively with cross-functional teams to drive results through effective sourcing, negotiations and contracting 

 Insight and knowledge regarding rates, unit costs, and costing structures to enable efficient negotiations. 

 Used external data sources, market information, and supplier engagement to constantly improve Regeneron’s knowledge of supply market dynamics. 

 Experience operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement. 

 Proven success supporting global supply market evaluation processes using all available market intelligence, risk, compliance, and financial assessment tools. 

 Experience managing associate level professionals preferred 

 Working knowledge with sourcing contracting tools, ERP’s, and eRFx systems preferred. (Oracle, Zycus, Ariba, Other) 
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Sr Manager, Global Procurement R&D - Regeneron 

Sr Manager, Global Procurement R&D

You must have a Master’s and 10 years or a Bachelor’s and 12 years in life sciences, strong critical thinking, communication skills, and the ability to influence and work independently.

You will manage process improvement, collaborate with partners on compliance, support audits, ensure timely procedural document delivery, and optimize resources for ongoing projects.

The Process &amp; Procedures (P&amp;P) Lead, Director is responsible for the end-to-end procedure development lifecycle. The Director role is responsible for collective multiple partner groups, understanding interdependencies and overall efficiencies through process optimization. We require the Director to act as a thought partner to support process effectiveness related to compliance and standard processes. We expect a great level of business insight, critical and thinking to support management of sophisticated issues that demand interaction with senior leadership in a highly matrixed environment. Process/Procedure development includes interpreting global and country specific functional business regulatory requirements and industry standards to deliver a portfolio of controlled procedural documents. The role will provide procedural expertise and work across multiple functions in Global Development to identify cross-functional dependencies and ensure project timelines are met. We believe you will be responsible for the review and management of the assigned portfolio and content standards including ongoing overall adherence to health authority compliance. As a member of the P&amp;P leadership team, this role will be responsible for coaching, management and development of direct reports. In this role, a typical day might include: 
 Understand the functional drivers and associated cross-functional processes and procedures within the assigned portfolio and in collaboration with senior team members build a strategic plan to identify and prioritize the need for new or updated procedures and processes. This includes end-to-end procedural life-cycle management. 
 Actively collaborate with functional partners/process owners, to manage identified process gaps and ensure timely and effective remediation aligned with current policies, regulations and business practices to ensure compliance. 
 Support functional inspections and audits including document requests, process reviews, and close out discussion as needed. 
 Accountable for timely delivery of high-quality procedural documents and performance tools across assigned functional areas by collaborating with process owners, procedural documentation writers and coordinators. 
 Oversee planning and execution of deliverables including ongoing resource allocation and optimization. This role might be for you if have: 
 Apply Critical thinking, both strategically and operationally to solve complex problems. 
 Proven track record to work effectively across multiple partners, with competing priorities and a high level of business sense. 
 Effective communicator (written and oral) 
 Ability to work independently and influence across, up and down the organization. 
 To be considered for this opportunity, we require a Master's degree and 10 years of experience or 12 years of experience with Bachelors within the life science industry. We also require you to be onsite three days a week at a minimum. 
 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
 For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
 Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

The Process & Procedures (P&P) Lead, Director is responsible for the end-to-end procedure development lifecycle. The Director role is responsible for collective multiple partner groups, understanding interdependencies and overall efficiencies through process optimization. We require the Director to act as a thought partner to support process effectiveness related to compliance and standard processes. We expect a great level of business insight, critical and thinking to support management of sophisticated issues that demand interaction with senior leadership in a highly matrixed environment. Process/Procedure development includes interpreting global and country specific functional business regulatory requirements and industry standards to deliver a portfolio of controlled procedural documents. The role will provide procedural expertise and work across multiple functions in Global Development to identify cross-functional dependencies and ensure project timelines are met. We believe you will be responsible for the review and management of the assigned portfolio and content standards including ongoing overall adherence to health authority compliance. As a member of the P&P leadership team, this role will be responsible for coaching, management and development of direct reports. In this role, a typical day might include: 
Understand the functional drivers and associated cross-functional processes and procedures within the assigned portfolio and in collaboration with senior team members build a strategic plan to identify and prioritize the need for new or updated procedures and processes. This includes end-to-end procedural life-cycle management. 
Actively collaborate with functional partners/process owners, to manage identified process gaps and ensure timely and effective remediation aligned with current policies, regulations and business practices to ensure compliance. 
Support functional inspections and audits including document requests, process reviews, and close out discussion as needed. 
Accountable for timely delivery of high-quality procedural documents and performance tools across assigned functional areas by collaborating with process owners, procedural documentation writers and coordinators. 
Oversee planning and execution of deliverables including ongoing resource allocation and optimization. This role might be for you if have: 
Apply Critical thinking, both strategically and operationally to solve complex problems. 
Proven track record to work effectively across multiple partners, with competing priorities and a high level of business sense. 
Effective communicator (written and oral) 
Ability to work independently and influence across, up and down the organization. 
To be considered for this opportunity, we require a Master's degree and 10 years of experience or 12 years of experience with Bachelors within the life science industry. We also require you to be onsite three days a week at a minimum. 
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Director, GD Process & Procedures - Regeneron 

Director, GD Process & Procedures

You need a Bachelor's with 2+ years in pharma, or 5+ years experience. Strong attention to detail, communication skills, problem-solving ability, and proactive assessment are essential.

You will coordinate meetings, track study progress, compile documents, manage data, communicate with sites, and support team initiatives while ensuring compliance and process improvements.

The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs). 
 This role is a hybrid position and must work onsite 3 days per week. Fully remote is not possible for this role. 
 
 In this role, a typical day might include the following:
 Organizes and delivers analyzable reports and metrics to the clinical study lead 
 Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings 
 Collates data for assessments such as feasibility and site selection and reviews site usability database 
 Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures 
 Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders 
 Collates materials for training and investigator meetings 
 Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan 
 Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings 
 Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance 
 Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form) 
 Manages and maintains team SharePoint and/or shared drive sites, as needed 
 Communication with sites as directed and maintains site contact information 
 Contributes to line listings review for Blind Data Review Meeting (BDRM) 
 May manage or contribute to oversight of Third-Party Vendors (TPV) 
 Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits 
 Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives 
 Proactively recommends process improvement initiatives for the department 
 
 This role might be for you if:
 You have a strong attention to details for the ability to track information and deliver on assigned study activities 
 You demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally 
 You are resourceful and to demonstrate problem solving skills 
 You can proactively assess information and investigate impact on clinical trials 
 In order to be considered , a Bachelor’s degree with 2+ years of relevant pharmaceutical industry experience. In lieu of a Bachelor’s Degree 5+ years of relevant pharmaceutical industry experience is required with a focus in clinical operations or trial management. 
 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
 For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
 Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. 
 Salary Range (annually) $106,200.00 - $173,200.00

The Clinical Study Specialist (CSS) provides technical and administrative support to the clinical study team(s) responsible for clinical trial execution. The CSS may be assigned to support the execution of one or more studies across a program. The CSS receives assignments from the Clinical Study Lead or Clinical Study Associate Manager. The CSS will support internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs). 
This role is a hybrid position and must work onsite 3 days per week. Fully remote is not possible for this role. 

 In this role, a typical day might include the following:
 Organizes and delivers analyzable reports and metrics to the clinical study lead 
Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings 
Collates data for assessments such as feasibility and site selection and reviews site usability database 
Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures 
Compiles study manuals including but not limited to study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders 
Collates materials for training and investigator meetings 
Tracks site activation, enrollment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan 
Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings 
Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance 
Ensures scheduled reports are received (i.e.,1572 reportable changes, financial disclosure form) 
Manages and maintains team SharePoint and/or shared drive sites, as needed 
Communication with sites as directed and maintains site contact information 
Contributes to line listings review for Blind Data Review Meeting (BDRM) 
May manage or contribute to oversight of Third-Party Vendors (TPV) 
Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits 
Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives 
Proactively recommends process improvement initiatives for the department 

 This role might be for you if:
 You have a strong attention to details for the ability to track information and deliver on assigned study activities 
You demonstrate strong communication and interpersonal skills; ability to form relationships internally and externally 
You are resourceful and to demonstrate problem solving skills 
You can proactively assess information and investigate impact on clinical trials 
In order to be considered , a Bachelor’s degree with 2+ years of relevant pharmaceutical industry experience. In lieu of a Bachelor’s Degree 5+ years of relevant pharmaceutical industry experience is required with a focus in clinical operations or trial management. 
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. 
Salary Range (annually) $106,200.00 - $173,200.00

Clinical Study Specialist - Regeneron 

Clinical Study Specialist

You need advanced interpersonal and leadership skills, 12 years in pharma, 8 in Clinical Trial Management, budget expertise, team-building experience, and a background in Internal Medicine.

You will oversee clinical study teams, manage timelines and budgets, provide operational insights, and ensure consistency in study design and processes throughout the program lifecycle.

This role is a hybrid position which requires a minimum 3 days on-site in Basking Ridge, NJ, Armonk, NY. Uxbridge, UK or Dublin, IRE. R 
 The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. In a typical day, you will: 
 Be responsible for the overall success of the clinical study team(s) within a program(s) 
 Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to partners as requested 
 Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development 
 Coordinates clinical study timelines within a clinical program(s) 
 Provides input and operational insight into Clinical Study Concepts (CSC) 
 Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol 
 Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of standard processes within CTM 
 Leads all aspects of clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate This job may be for you if you have: 
 Advanced interpersonal &amp; leadership skills 
 Ability to provide operational strategic direction and guidance for clinical programs 
 Applies sophisticated technical knowledge to solve highly complex issues 
 An understanding of relevant industry trends 
 Strong analytical skills with a data driven approach to planning, executing, and problem solving 
 Advanced interpersonal skills via verbal, written and presentation abilities 
 Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization 
 Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads) 
 Budget management expertise and strong financial competence 
 Consistent track record of building, leading and developing productive teams and collaborations 
 Expert project management skills, cross-functional engagement and organizational skills 
 To be considered, you must have a Bachelor's degree and minimum of 12 years relevant in-house sponsor-side pharmaceutical industry experience, 8 years within Clinical Trial Management. 
 Experience in Internal Medicine is highly preferred (obesity, metabolism, diabetes, cardiovascular). Experience in Phase 4 trials is highly preferred. Previous people management experience required. 
 Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
 Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
 For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
 Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. 
 Salary Range (annually) $198,000.00 - $330,000.00

This role is a hybrid position which requires a minimum 3 days on-site in Basking Ridge, NJ, Armonk, NY. Uxbridge, UK or Dublin, IRE. R 
The Program Operations Leader (POL) will lead and implement the operational strategy for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is responsible for clinical operations activities and decisions including quality, timelines and budgets related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and company Standard Operating Procedures (SOPs) within assigned program(s). The POL is a member of the Clinical Trial Management extended leadership team, and as such interacts with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. The POL is responsible for line management of clinical trial management staff (including AD POL), and has responsibility for staff recruitment, development, coaching, mentoring and performance management. Plays a key role in driving the functional strategy of Clinical Trial Management in partnership with Functional leadership. The Director POL is expected to operate with autonomy and high-degree of independence. In a typical day, you will: 
Be responsible for the overall success of the clinical study team(s) within a program(s) 
Maintains an overview of clinical program(s) status and issues and proactively communicates progress, risks, issues or changes that may impact quality, timelines and/or budget; provide clinical program level updates to partners as requested 
Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development 
Coordinates clinical study timelines within a clinical program(s) 
Provides input and operational insight into Clinical Study Concepts (CSC) 
Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical Study Concept through Final Protocol 
Review of plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensure consistency within the program and development of standard processes within CTM 
Leads all aspects of clinical study budgets within a program: ensures review, presentation and approval of initial study budget and manages the budget through the lifecycle of the program by communicating changes to TA Operations Leader, as appropriate This job may be for you if you have: 
Advanced interpersonal & leadership skills 
Ability to provide operational strategic direction and guidance for clinical programs 
Applies sophisticated technical knowledge to solve highly complex issues 
An understanding of relevant industry trends 
Strong analytical skills with a data driven approach to planning, executing, and problem solving 
Advanced interpersonal skills via verbal, written and presentation abilities 
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization 
Ability to influence and negotiate across a wide range of senior partners (i.e., functional area heads) 
Budget management expertise and strong financial competence 
Consistent track record of building, leading and developing productive teams and collaborations 
Expert project management skills, cross-functional engagement and organizational skills 
To be considered, you must have a Bachelor's degree and minimum of 12 years relevant in-house sponsor-side pharmaceutical industry experience, 8 years within Clinical Trial Management. 
Experience in Internal Medicine is highly preferred (obesity, metabolism, diabetes, cardiovascular). Experience in Phase 4 trials is highly preferred. Previous people management experience required. 
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! 
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. 
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. 
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. 
Salary Range (annually) $198,000.00 - $330,000.00

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