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(Senior) Regulatory Manager

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Precision Medicine Group

2mo ago

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Madrid
    Remote
  • Quick Apply

AI generated summary

  • You need a relevant degree, 5-7 years in regulatory affairs, experience with clinical submissions, knowledge of drug development and regulations, and availability for travel.
  • You will provide regulatory guidance, review submissions, lead project teams, oversee specialists, maintain project plans, and ensure compliance with drug development regulations.

Requirements

  • Minimum Required:
  • Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
  • 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level
  • Computer literacy (MS Office/ Office 365)
  • Fluent in English
  • Preferred:
  • Graduate, postgraduate
  • Possesses basic understanding of financial management
  • Other Required:
  • Candidates must have regulatory affairs experience working for a Clinical Research Organisation and have experience leading Clinical Submissions
  • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions.
  • Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
  • Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
  • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
  • Availability for domestic and international travel including overnight stays

Responsibilities

  • Provides regulatory guidance throughout the clinical development life cycle
  • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
  • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
  • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
  • Works within a project team, and where necessary, leads project for the region or globally
  • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
  • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
  • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
  • Provide input, as required, into regulatory strategy and timeline development for new study opportunities
  • Assists in establishing company standards to ensure the highest quality of submitted information
  • Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions
  • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
  • Provides ICH GCP guidance, advice and training to internal and external clients
  • Serve as representative of Global Regulatory Affairs at business development meetings

FAQs

What is the primary role of a Regulatory Manager at Precision for Medicine?

The primary role of a Regulatory Manager is to provide regulatory strategy and development guidance for optimal conduct of clinical trials, coordinate and prepare regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, and ensure compliance with applicable regulations throughout the clinical development life cycle.

What qualifications are required for this position?

Candidates must have a Bachelor's degree, or equivalent experience, ideally in a scientific or healthcare discipline, with a minimum of 5 years of regulatory experience for the Manager level and 7 years for the Senior Manager level. Fluency in English and computer literacy (MS Office/Office 365) are also required.

Which countries can candidates be based in for this position?

Candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland.

What type of regulatory submissions is the Regulatory Manager responsible for?

The Regulatory Manager is responsible for compiling, coordinating, and reviewing regulatory applications such as CTA/INDs, annual reports, routine amendments, orphan designations, pediatric planning, marketing applications, and conducting scientific advice/regulatory authority meetings.

Is travel required for this position?

Yes, candidates must be available for domestic and international travel, including overnight stays.

What experience is preferred for candidates applying for this role?

Preferred candidates will have a graduate or postgraduate degree, and a basic understanding of financial management.

What specific knowledge should a candidate possess for this role?

Candidates should have informed knowledge of all aspects of the drug development process, regulatory milestones, and specialized knowledge of regulatory activities for major regions such as the EU or US, including submissions to Regulatory Authorities and post-approval submissions.

What are the key competencies required for this position?

Key competencies include strong interpersonal skills, professionalism, the ability to manage multiple tasks, high self-motivation, problem resolution skills, a focus on continuous improvement, effective communication, and the ability to conduct formal presentations.

Does Precision for Medicine provide opportunities for professional development?

Yes, the job description mentions assisting in the development of Regulatory Affairs Specialists and other operational staff, indicating that there are opportunities for professional development and growth within the organization.

Is Precision for Medicine an equal opportunity employer?

Yes, Precision Medicine Group is an Equal Opportunity Employer, and employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

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Precision Medicine Group

Moving Science Closer to Health

Science & Healthcare
Industry
1001-5000
Employees
2012
Founded Year

Mission & Purpose

We founded Precision Medicine Group in 2012 because we believed there was a transformational opportunity to improve the process of bringing new drugs to market. It involves utilizing technology, data, and human expertise. It is a big challenge that requires diverse talents. Our model involves both nurturing and investing organically and acquiring capabilities that we do not have but critically need. Our core executive team is anchored to this model, building life science services that address fundamental changes in healthcare that are necessary for health and outcomes improvement.