Title: Senior Director, Global Regulatory Affairs
Summary: A world renowned leader in the pharmaceutical industry is seeking a Regulatory Affairs expert to join their team. Acting as a global lead on their vaccines team, this professional will act as a regulatory strategist for programs both in the post-approval phases and development phases. This global leader will provide regulatory oversight for multiple projects, working cross-functionally with all regional counterparts on non-clinical and clinical aspects of drug development. The right professional is a passionate expert in Regulatory Affairs with leadership skills and extensive experience in global drug development, specifically with Vaccines or Biologics.
The Senior Director, Global Regulatory Affairs is responsible for:
- Developing, implementing, and prioritizing global regulatory strategy for assigned Vaccines projects
- Collaborate with cross-functional teams and corresponding regional teams in the Vaccines group to resolve conflicts to global regulatory strategy and ensure successful submissions.
- Lead meetings with Health Authorities for assigned projects, as well as keeping up to date on regulatory requirements and updates across relevant global Health Authorities.
- Oversee all regulatory submissions and approvals for assigned projects, ensuring successful execution of Global Regulatory Strategy
The Senior Director, Global Regulatory Affairs should have the following qualifications:
- Bachelor's degree in science required, advanced degree preferred.
- 8+ years of Regulatory Affairs experience, with 10+ years of experience in the pharmaceutical industry and extensive experience in late-stage drug development
- Global Regulatory Strategy experience, with an understanding of complex scientific issues in Vaccines and/or Biologics
- Ability to lead multiple projects, demonstrated cross-functional leadership skills, and a collaborative, team-oriented approach.
If you are interested in the Senior Director, Global Regulatory Affairs role, then please don't wait to apply.