Director Regulatory Affairs: Vaccines, Biologics; development

Brussels, Belgium
car + package
19 Feb 2021
26 Feb 2021
Michael van
Regulatory Affairs
Full Time
Contract Type
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)