Director Regulatory Affairs
Director, Global Regulatory Affairs (Oncology)
Location: South San Francisco, CA (Hybrid)
Remote: Can be considered
Compensation: $235-270K base + 20% bonus + equity
Target Start: Mid‑April
About the Company
Our client is a global, commercial‑stage biopharmaceutical company developing innovative therapies for serious diseases with unmet need in oncology and immunology. With a growing U.S. footprint and a robust late‑stage pipeline, they are expanding their Regulatory Affairs function to support upcoming global filings and long‑term growth. With multiple marketed products and more being developed in the clinic, this company is growing quickly with a lot of runway.
Role Overview
They are seeking a Director, Global Regulatory Affairs to lead global regulatory strategy for a late‑stage oncology asset approaching BLA and ex‑U.S. marketing applications. This is a high‑visibility role supporting a small but scaling U.S. regulatory team in close collaboration with global counterparts.
Key Responsibilities
- Lead global clinical regulatory strategy for a late‑stage oncology program.
- Drive BLA and MAA planning and execution.
- Serve as the primary regulatory lead for FDA and EMA interactions.
- Develop high‑quality regulatory documents including briefing packages, responses, and submission components.
- Partner with cross‑functional teams across Clinical Development, Safety, Medical, and Program Leadership.
- Collaborate with global regulatory colleagues to ensure regional alignment.
- Identify regulatory risks and propose mitigation strategies.
- Represent Regulatory Affairs in internal governance forums.
- Contribute to process improvements as the U.S. team expands.
- Monthly travel to South San Francisco required for non‑local candidates.
Qualifications
- 12+ years of Regulatory Affairs experience in biopharma.
- Late‑stage oncology regulatory background
- BLA experience (strategy, authorship, or major ownership).
- Proven track record as a Global Regulatory Lead or equivalent.
- Strong communication, strategic, and cross‑functional leadership skills.
Preferred
- Advanced degree (PhD, PharmD, MS).
- Experience with ADCs, biologics, or next‑generation oncology modalities.
- Experience collaborating across U.S., EU, and Asia regions.
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