CK Clinical are recruiting for a Senior Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will work across therapies including biosimilars and lead the regulatory strategy across Europe. A true chance to innovate and lead.Location:
Uxbridge or Cambridge – some working from home.
Senior Regulatory Affairs Manager Role:
- Lead of team of Regulatory Managers.
- Representing the region, provide advice on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
- Plan and manage regulatory submissions (e.g. clinical trial and marketing applications).
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning.
- Lead development of regional regulatory documents and meetings.
- Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, PRIME, compassionate use and paediatric plans).
- Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately.
- Degree in a scientific discipline.
- Extensive experience in regional regulatory environment.
- Proven track record of developing and executing regional regulatory strategy.
- In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Ability to lead teams and work collaboratively in a dynamic environment.
For more information or to apply for this Senior Regulatory Affairs Manager position, please contact Andy Leake on 01438 842966 or email firstname.lastname@example.org, quoting job ref 51068.
It is essential that applicants hold entitlement to work in the UK.