Senior Director, Global Regulatory Affairs
: Job Details :

Director/Senior Director, Global Regulatory Affairs

*Candidates are ideally based in San Francisco, CA - remote candidates who are available to travel will also be considered*

Meet has partnered with a Bay Area-based rare disease biotech that is looking for a Director or Senior Director of Regulatory Affairs to join their team! This position will be focusing exclusively within ex-US Regulatory Strategy (EU, APAC, LATAM).

Key Responsibilities

• You will lead the development of international regulatory strategies across your assigned programs.
• You will collaborate with local partners and CRO's to ensure the preparation and submission of regulatory documents.
• You will provide regulatory guidance to a variety of cross-functional stakeholders for product development planning

Key Experience

• 10+ years of Regulatory Strategy experience, 5+ specifically in Global RA
• Experience supporting ex-US submissions required (CTA/MAA)
• Experience liaising (directly or indirectly) with ex-US health authorities (EMA, MHRA, PMDA..)
• Rare disease experience highly preferred

Please feel free to reach out directly to learn more:

✉: ...@peoplewithchemistry.com