Product Features
Blog
Contact Us
Sign In
NonStop Recruitment
,
London, Greater London
Director Regulatory Affairs: Vaccines, Biologics; development
Overview
Job Description
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)