Senior Regulatory Affairs Manager, Oncology
CK Clinical are recruiting for a Senior Regulatory Affairs Manager to join a Global leading Biotechnology company. The role will work within oncology 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 a 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.
- Experience in Oncology is strongly preferred.
Apply: For more information or to apply for this Senior Regulatory Affairs Manager, Oncology position, please contact Andy Leake on 01438 842966 or email firstname.lastname@example.org, quoting job ref 51067.
It is essential that applicants hold entitlement to work in the UK.itlement to work in the UK is essential.experience within a pharmaceutical/bio-tech company (medical department/non-promotional)
- Sufficient scientific expertise to understand the oncology therapy area in terms of emerging scientific trends, drug development, market demands and patient needs.
- Experience of building and maintaining strong relationships with KOLs and forming networks
- Demonstrate flair, enthusiasm, innovation and an ability to be a self-starter.
- Low ego with strong EQ skills – able to network and interact with very senior global oncologists and endear them to the Ellipses mission
Entitlement to work in the UK is essential. For more information or to apply for this Oncology Scientific Liaison role, please contact Julia Day on 01246 457719 or email email@example.com. Alternatively, please click on the link below to apply online now. Please quote reference 52033 in all correspondence.
- Good understanding of current UK health care system and market access issues
- Demonstrated experience of project management
- Strong numeric skills
- Scientific/medical knowledge
- A commercial mindset
Apply: Entitlement to workin the UK is essential. For more information or to apply for this Health Economics Manager position, please contact Steve Lord on 01246 457733 or email firstname.lastname@example.org. Please quote reference 52358 in all correspondence.