Senior Manager, International Regulatory Affairs

CK Group
£55000 - £70000 per annum
12 Feb 2021
12 Mar 2021
Sam Whyley-Smith
Contract Type
Full Time
CK Group are recruiting for a Senior Manager, International Regulatory Affairs to join a biotechnology company home based on a permanent basis.

Senior Manager, International Regulatory Affairs Role:

The Senior Regulatory Manager is responsible for worldwide registrations and regulatory compliance throughout the lifecycle management of these marketing authorizations, under the oversight of the Global Head of Regulatory Affairs and Compliance and in collaboration with other Corporate functions as needed.

Key responsibilities will include:
  • Definition and implementation of regulatory strategies, organization and planning of regulatory affairs activities.
  • Leading or co-leading the preparation and filing of both first registration and post-approval packages, in alignment with internal functions (CMC, clinical, etc.) as well as external partners in International markets.
  • Follow-up of applications for marketing authorization, answers to questions from regulatory authorities and compilation of necessary supplements.
  • Drafting, follow-up and/or review of post approval applications (renewals, variations) to ensure the maintenance of marketing authorisations.
  • Supporting product launch, tenders, and interface with distributors on regulatory aspects.

Your Background:
  • Higher degree (M.Sc; Pharm.D or PhD) in Pharmacy or Life Sciences.
  • Minimum 8 years of experience in a similar role at international level, preferably in SMEs and/or in a consultancy role.
  • Substantial experience in obtaining and maintaining product licenses worldwide, particularly in International Markets; of particular interest APAC and LATAM regions.
  • Solid knowledge of regulations at European and international level.
  • Cross-functional leadership, strategic vision and negotiation skills.

For more information or to apply for this Senior Manager, International Regulatory Affairs position, please contact CK Group, quoting job ref 49813.

It is essential that applicants hold entitlement to work in the UK.

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