CK Clinical are recruiting for a Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will support the general medicine group across Europe.
Cambridge or Uxbridge – some working from home.Regulatory Affairs Manager Role:
- Plan and manage regulatory submissions (e.g. clinical trial applications, variations and supporting marketing applications).
- Develop and/or implement innovative and compelling regulatory strategies.
- Lead and/or participate in development of regional regulatory documents.
- Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans).
- Degree in a scientific discipline.
- Proven experience in Regulatory Affairs in a pharmaceutical company.
- In-depth understanding of the European registration procedures for CTA, MA, post approval changes, extensions and renewals.
For more information or to apply for this Regulatory Affairs Manager position, please contact Andy Leake on 01438 842966 or email email@example.com, quoting job ref 51070.
It is essential that applicants hold entitlement to work in the UK.