Lead Regulatory Scientist

CK Group are recruiting for Lead Regulatory Scientist to join a leading pharmaceutical company based in Welwyn Garden City on a 12 month contract basis. The roles have been deemed as Inside IR35 so working options are PAYE via CK, or Umbrella Companyonly.

Lead Regulatory Scientist Role: In this Senior regulatory role you will provide strategic and technical advice within the department and across the business, and be responsible for regulatory management of marketed medicines in the UK and innovative development products that will be submitted post EU exit.

The main purpose of the role will be to:

• Support the department in preparations for Brexit.
• Represent UK Regulatory Affairs (DRA) both externally, internally at EU/HQ level, and in cross-functional teams to support the business.
• Lead in interactions with national regulatory agencies on policy, scientific advice and product issues.
• Give strategic and relevant regulatory input to support development and lifecycle management.
• Know the brand strategies, ensuring timely communication of regulatory activities and timelines to support brand planning.
• Build contacts and understanding across the business, identifying business opportunities for Regulatory Affairs.

Your Background:

• University degree or equivalent, preferably in a scientific discipline. Further education or training in Regulatory Affairs desirable.
• Successful track record in Regulatory Affairs, including stakeholder management and experience of UK or EU management of Marketing Authorisations and CTAs.
• Experience in other aligned areas e.g. drug safety, clinical trials, discovery or development research (desirable)
• Planning and project management of large, complex activities

Apply:

Entitlement to work in the UK is essential. For more information or to apply for this Lead Regulatory Scientist position, please contact Sam Cupit via phone 01246457733 or email scupit@ckgroup.co.uk. Please quote reference 52162.Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Location:

This Global Nominated Signatory rolewill be based at our clients site in Cambridge.

Apply:

For more information, please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 52222.

It is essential that applicants hold entitlement to work in the UK.utcomes, retrospective and prospective data analyses, registry, epidemiology or health services research

• Expert insight and knowledge in Health economics and model development
• Skilled in translating complex economic concepts into simple language.
• 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.