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.

Your Background:

• 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 aleake@ckgroup.co.uk, 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

Apply:

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 jday@ckgroup.co.uk. Alternatively, please click on the link below to apply online now. Please quote reference 52033 in all correspondence.

CLINGENe.

• 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 slord@ckgroup.co.uk. Please quote reference 52358 in all correspondence.