Director Regulatory
A rapidly growing specialty pharmaceutical organization is seeking a seasoned Director of Regulatory Affairs to lead regulatory strategy from their Bay Area. This company develops and commercializes treatments for genetic, metabolic, systemic, and life‑threatening disorders, and is expanding its footprint across international markets. The Director will shape regulatory pathways across early development, late‑stage programs, and post‑approval activities, ensuring products achieve and maintain global market access. This is a high‑impact, highly visible role reporting directly into executive leadership, offering the opportunity to influence global strategy and collaborate with world‑class scientific experts. This role offers the chance to work alongside top scientific leaders, gain significant commercial exposure, and directly contribute to therapies that improve patients' lives.
The Director will be responsible for…
- Developing and implementing global regulatory strategies across development programs
- Providing strategic and operational regulatory guidance to cross‑functional teams
- Leading interactions and face‑to‑face meetings with FDA, EMA, and other Health Authorities
- Overseeing, contributing to, and preparing global regulatory submissions (NDA, MAA, eCTD)
- Managing regulatory documentation supporting marketing applications and post‑approval changes
- Conducting due diligence assessments and developing risk‑mitigation strategies
- Maintaining deep knowledge of global regulatory requirements, guidelines, and evolving landscapes
- Supporting market access activities including pricing, contracts, and product listings
The Director should have the following qualifications:
- 15+ years of regulatory affairs experience with progressive leadership responsibility
- Strong working knowledge of FDA, EMA, ICH, and global regulatory frameworks
- Proven experience leading Health Authority meetings and securing approvals in the US and EU
- Expertise spanning early development through post‑approval lifecycle management
- Experience preparing NDAs, MAAs, INDs, BLAs, and obtaining Orphan Drug Designations
- Strong leadership, communication, and team‑development skills
- High attention to detail, integrity, and the ability to manage complex timelines
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