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.
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.
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.
- 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.
For more information, or to apply for this Senior Regulatory Portfolio Manager position please contact the Key Accounts Team on 01438 870011 or email email@example.com. Please quote job reference 56301 in all correspondence.
It is essential that applicants hold entitlement to work in the UK