Head of Regulatory Affairs
Location: Fremont/Newark, CA (Onsite 3 days per week)
Level: Senior Director – Vice President
We are seeking an experienced and strategic Regulatory Affairs leader to join a growing biotechnology organization focused on advancing innovative oncology and hematology therapies. This individual will lead global regulatory strategy for large molecule programs spanning early development through commercialization and will play a critical role in shaping regulatory direction across the portfolio.
The ideal candidate will bring deep expertise in biologics/large molecules, extensive oncology and/or hematology experience, and a proven track record of direct FDA engagement and successful regulatory leadership from Phase 1 through approval and post-marketing activities.
Key Responsibilities:
- Lead and execute global regulatory strategies for oncology and hematology biologic programs from Phase 1 through commercialization.
- Serve as the primary regulatory lead for direct interactions with the FDA, including End-of-Phase meetings, Type B meetings, pre-BLA interactions, and advisory committee preparation where applicable.
- Provide strategic regulatory guidance on clinical development, CMC, labelling, lifecycle management, and commercialization plans.
- Drive preparation, review, and submission of INDs, BLAs, CTAs, briefing documents, orphan drug applications, expedited designation requests, and other regulatory filings.
- Lead regulatory agency meeting strategy, preparation of briefing packages, and cross-functional coordination for health authority interactions.
- Partner closely with Clinical Development, Medical Affairs, CMC, Quality, Manufacturing, and Commercial teams to align regulatory strategy with broader program objectives.
- Assess regulatory risks, identify opportunities, and provide clear strategic recommendations to executive leadership.
- Contribute to regulatory policy and competitive intelligence efforts within oncology and hematology landscapes.
- Build and strengthen regulatory infrastructure, processes, and team capabilities in support of organizational growth.
- Support due diligence, partnering activities, and investor-related regulatory communications as needed.
Qualifications
- Advanced scientific degree preferred (PhD, PharmD, MD, or MS in a relevant discipline).
- 12+ years of Regulatory Affairs experience within biotech or pharmaceutical organizations.
- Significant experience supporting oncology and/or hematology therapeutic programs.
- Strong background in biologics and/or other large molecule therapeutics.
- Demonstrated success developing and executing regulatory strategy from Phase 1 through commercial approval.
- Extensive direct experience leading interactions and negotiations with the FDA.
- Proven experience authoring and leading major regulatory submissions including INDs and BLAs.
- Strong understanding of accelerated and expedited regulatory pathways relevant to oncology and hematology programs.
- Excellent leadership, communication, and cross-functional influencing skills.
- Prior experience in a fast-paced or emerging biotech environment preferred.
Preferred Experience
- Experience with breakthrough therapies, orphan indications, and accelerated approval pathways.
- Global regulatory experience outside the US, including EMA interactions.
- Prior experience building or scaling Regulatory Affairs functions and teams.
Work Environment
- Hybrid onsite model requiring presence in the Fremont/Newark office three days per week.
- High-visibility strategic role with significant executive and cross-functional interaction.