Director Regulatory Affairs: Vaccines, Biologics; development
- Experience Level
- Senior Management
My client, a large pharmaceutical company, is looking for their next Director of Regulatory Affairs to head their Vaccines & Biologics division.
As a part of the regulatory team, your role as director will be to properly coordinate all regulatory projects and make sure the RA division is running like a well-oiled machine.
Responsibilities include but are not limited to:
- Manage people in your team and for the assigned projects;
- Develop EU product regulatory strategy and optimise label, obtain shortest time to approval by regulatory agencies
- Develop product regulatory strategy for non-EU countries in the RAE region (CH and non-EU CES)
- Oversee the maintenance of all vaccines & biologicals in your assigned therapeutic area and be responsible for regulatory compliance of these products in the EU region;
- Responsible for all RA procedures in the region for the assigned projects and therapeutic area, including PIP applications, local and regional Scientific Advice, MRP, DCP, CP and national procedures
- Conduct due diligence licensing candidate review;
- Responsible for regulatory review and final approval of all submissions and associated documentation for the assigned vaccines/ biologicals;
- Provide support to the RA subsidiary team on subjects related to the projects or therapeutic area
- Provide EU expertise to the worldwide RA team, the product development teams and the Vaccines franchise;
- Be a recognised, internal expert (SME) for one or more aspects of regulatory policy and recognised as a scientific expert in one or more therapeutic areas.
Your ideal profile:
- Formal scientific background (Master's degree minimum in pharmaceutical sciences, biochemistry, etc...)
- At least 8-10 years of experience in Regulatory Affairs on Development level. Life Cycle Management experience strongly appreciated
- Previous experience with Vaccines/Biologics is required; experience with Infectious Diseases is a big plus
- Strong people management skills
- Strong negotiation skills (for contact with relevant authorities)