Regulatory Affairs Manager / Senior Manager, CMC

We are currently recruiting for a Regulatory Affairs Manager / Senior Regulatory Manager to join an International Biopharmaceutical company based in Oxfordshire and specialising within Oncology and Neurology.

This is an exciting time to join a growing company with a strong portfolio and pipeline of products.

Responsibilities:

, Planning and co-ordination of the authoring and reviewing of Module 2 (QOS) and Module 3 sections of regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents), as assigned.
, Leads functional/department multi-disciplinary teams in complex, business critical projects to establish Regulatory CMC strategies for commercial products and/or, late, and early stage development programs.

Solve unique and complex problems that have a broad impact on the function and/or broader department.
, Regularly interacts with functional leaders, and in some cases senior leadership and/or major customers, on matters concerning functional area, business unit or additional business areas., including regulatory agency interactions.
, Coordinate the preparation and timely submission of responses to regulatory agencies.

Manage timelines to ensure approvals are timely and development objectives are met.
, Monitor EU and US CMC regulations and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
, Ensure continued regulatory compliance of products though adherence to the change control procedures and completion of regulatory impact assessments for assigned commercial products.

Required Knowledge and Experience:

, Demonstrated understanding and strategic application of regulations and guidelines for drug development and commercial supply.
, Demonstrated knowledge of CMC regulatory and ability to generate clear, well-argued positions.
, Must have experience with electronic Common Technical Document CMC regulatory documents (MAA, BLA, variations, responses and CTAs/INDs).
, Demonstrated understanding of FDA, EMA and ICH guidelines.
, Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators.
, Demonstrated ability to influence and impact their functional area and department practices
, BSc/BA with a minimum of eight years of regulatory CMC experience.
, English language - written and verbal communication skills.

For further details about this role, or other vacancies within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


  • Start: a.s.a.p
  • Rate: £60000 - £80000 per annum + bonus and benefits
  • Location: Oxfordshire, England
  • Type: Permanent
  • Industry: Pharmaceutical
  • Recruiter: Key People
  • Tel: +44 (0)1727 817 626
  • Fax: 01727 844 838
  • Email: to view click here
  • Posted: 2020-04-22 20:14:39 -

  • View all Jobs from Key People


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