Senior Manager Regulatory Affairs

REG3042024_1717523562
  • £58 - £64 PER HOUR
  • Cambridge, Cambridgeshire
  • Contract

Position: Senior Manager Regulatory Affairs

Location: Cambridge, UK
Work Structure: Monday - Friday, 37.5 hours per week
Pay Rate: £58 - £64/hour (Inside IR35)

Job Summary:

Our client, a multinational pharmaceuticals company, are seeking a Senior Manager Regulatory Affairs! The successful candidate will provide country regulatory expertise for the development, registration, and life-cycle management of all molecules within our client's portfolio!

Key Responsibilities for the Senior Manager Regulatory Affairs may include:

  • Align local regulatory requirements with corporate standards.
  • Provide national/regional input and execute regulatory strategies.
  • Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
  • Act as the point of contact with regulatory agencies.
  • Contribute to the filing plan (MA and Life-cycle maintenance) and discuss it with the local cross-functional team.
  • Execute the filing plan for their country(ies) with minimal supervision
  • Collaborate with Regional and Global Study Operations teams to support local planning and execution for clinical studies.
  • Act as the point of contact with regulatory agencies to fulfill local obligations.

Education & Experience:

  • Degree and in-depth regulatory experience related to the country(ies).
  • Depth of knowledge in country(ies) legislation and regulations related to medicinal products.

Knowledge and Skills:

  • Knowledge of regulatory principles and experience with policies, procedures, and SOPs.
  • Comprehensive understanding of regulatory activities and their impact on other projects and processes.
  • Good knowledge of national legislation and regulations related to medicinal products.
  • Awareness of registration procedures/challenges in the country(ies) for CTAs, MAs, and lifecycle management activities.
  • Knowledge and experience in the local regulatory environment relevant to the product area and development stage.
  • Understanding of drug development and ability to anticipate regulatory agency questions.
  • Cultural awareness and sensitivity to achieve results across regional, country, and international borders.

How to Apply:

If you possess the expertise and qualities required for this challenging yet rewarding role, please submit your application including your CV to jkirlew@i-pharmconsulting.com or press the apply button below!

Please note: You must be able to work in the UK without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Jada Kirlew at jkirlew@i-pharmconsulting.com or call: +44 (0)20 7551 0727

Jada Kirlew Senior Candidate Consultant I

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