Senior Regulatory Portfolio Manager

CK Group are recruiting for a Senior Regulatory Portfolio Manager to join a global pharmaceutical company, based in Uxbridge on a contract basis for 12 months. This role is remote.

Salary: £45.60 per hour PAYE. This role is inside IR35.

Company:

Our client is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. They have the goal of putting patients first and tohelp people around the world live better and healthier lives.

Location:

Uxbridge. This is the commercial head office for UK & Ireland. It includes Clinical Operation, Health Economics, Pharmacovigilance and Regulatory Affairs amongst other functions. This role is remote.

Senior Regulatory Portfolio Manager Role:

• Partner with Regulatory Leads and wider Global Regulatory Sub-Team to deliver and execute the optimal regulatory strategy for assigned assets.
• Track key regulatory milestones as defined by the GRST., health authority meetings, post-approval commitments, annual reports, etc.
• Maintain global submission plans including oversight of the interdependencies across regions for timely execution aligned with the asset’s priorities
• Co-ordinate preparation of regulatory components for US submissions and author assigned documents and support and co-ordinate preparations for FDA meetings.

Your Background:

• Educated to degree level or above in Life Sciences or a related field with significant experience in Regulatory Affairs roles.
• Knowledge of EU and US Regulatory Procedures.
• Ability to work independently and at pace in a global matrix environment and effectively prioritise.
• Excellent Communication and negotiation skills.

Apply:

For more information, or to apply for this Senior Regulatory Portfolio Manager position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote job reference 56301 in all correspondence.

It is essential that applicants hold entitlement to work in the UK