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.
A top 10 global biotechnology company.
Uxbridge or Cambridge ? some working from home
Circa £80,000 with an excellent package
- 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
Please quote reference 51068 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Julia Day
- Phone: 01246 457733
- Reference: 51068
Website: CK Group
- Posted: 8th July 2021
- Expires: 5th August 2021