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Associate/Sr Associate - Regulatory CMC, Regulatory Delivery & Excellence (RD&E)

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Lilly

Yesterday

  • Job
    Full-time
    Entry, Junior, Mid & Senior Level
  • Research & Development
    Healthcare
  • Cork

AI generated summary

  • You need a Bachelor’s in a scientific field, knowledge of drug development and submission procedures, strong communication, teamwork, negotiation skills, and attention to detail.
  • You will manage CMC submissions, collaborate with scientists on content preparation, address regulatory inquiries, implement global standards, and foster open discussions within teams.

Requirements

  • Bachelor’s Degree in a scientific or health sciences discipline (e.g., pharmacy, chemistry, or related scientific discipline)
  • Knowledge of pharmaceutical drug development or industry-related experience preferred.
  • Drug development process or Industry-related experience
  • Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
  • Ability to operate and manage operational requirements in a regulated environment
  • Written, spoken and presentation skills
  • Negotiation and influence skills
  • Attention to detail and ability to effectively prioritize
  • Proven effective teamwork skills; able to adapt to diverse interpersonal styles.

Responsibilities

  • Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
  • Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products.
  • Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
  • Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions.
  • Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Lilly affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.
  • Create an environment within the Global Regulatory Area and across CMC development teams that encourages open discussions on issues to achieve a robust outcome on project decisions. Constructively challenge teams to reach the best solutions to issues.
  • Leverage internal forums to continue to develop and share regulatory and drug development expertise to meet critical product registration timelines and electronic submission structure and content requirements.
  • Communicate effectively to guide and influence within work group/function and with development team regarding life-cycle management processes.
  • Demonstrate strong problem-solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies.

FAQs

What is the job title for this position?

The job title is Associate/Sr Associate - Regulatory CMC, Regulatory Delivery & Excellence (RD&E).

Where is Eli Lilly headquartered?

Eli Lilly is headquartered in Indianapolis, Indiana.

What type of contract is being offered for this position?

This is a 12-month contract position.

What are the primary responsibilities of the Associate in this role?

The Associate will lead CMC submission management processes, partner with GRA-CMC Scientists, manage communications with Lilly Affiliates, and support global regulatory requirement assessments and strategy developments.

What qualifications are required for this position?

A Bachelor's Degree in a scientific or health sciences discipline is required, along with preferred knowledge of pharmaceutical drug development or related industry experience.

What is the work environment like at Eli Lilly Cork?

Eli Lilly Cork offers a premium workspace across a campus in Little Island, with flexible hybrid working options, healthcare, pension and life assurance benefits, and various wellbeing initiatives.

What emphasis does Eli Lilly Cork place on diversity, equity, and inclusion?

Eli Lilly Cork is committed to promoting diversity, equity, and inclusion through various initiatives and support groups, ensuring an inclusive culture for all employees.

Does the position require experience in submissions and regulatory procedures?

Yes, knowledge of agency submission procedures and practices, as well as experience in a regulated environment, is preferred.

Are there any specific skills emphasized for candidates in this role?

Candidates should demonstrate strong problem-solving skills, written and spoken communication abilities, negotiation skills, attention to detail, and effective teamwork skills.

How can individuals with disabilities request accommodations during the application process?

Individuals can request accommodations by completing the accommodation request form available on the Lilly careers website for assistance during the application process.

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Manufacturing & Electronics
Industry
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Employees
1876
Founded Year

Mission & Purpose

Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.