CK Clinical are recruiting for a Regulatory Affairs Manager, Oncology to join a Global leading Biotechnology company. The role will support the Oncology group across Europe.
Cambridge or Uxbridge – some working from home.Regulatory Affairs Manager, Oncology Role:
- Plan and manage regulatory submissions (e.g. clinical trial applications, variations).
- 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.
- Experience in oncology is strongly preferred.
- In-depth understanding of the European submissions procedures.
For more information or to apply for this Regulatory Affairs Manager, Oncology position, please contact Andy Leake on 01438 842966 or email email@example.com, quoting job ref 51069.
It is essential that applicants hold entitlement to work in the UK.