Vice President/Senior Vice President Regulatory Affairs
Job Title: Senior Vice President / Vice President, Regulatory Affairs
Location: California - San Diego or South San Francisco Metropolitan Areas
Our client is a clinical-stage biopharmaceutical company focused on overcoming treatment resistance in oncology through precision small-molecule therapies. With multiple late-stage programs in high-value indications, they are entering a critical growth phase with Phase 3 readiness and commercialization on the horizon.
The Role
This is a senior leadership position responsible for defining and executing global regulatory strategy across all development stages. You will oversee regulatory submissions worldwide, lead interactions with health authorities, and build a high-performing regulatory organization that supports multiple programs through approval and launch.
Key Responsibilities
- Develop and implement global regulatory strategies for late-stage oncology programs
- Lead major submissions (IND, CTA, NDA/BLA, MAA) and ensure compliance with global requirements
- Serve as primary contact for FDA and other health authorities; manage regulatory negotiations
- Provide strategic input on clinical development plans, lifecycle management, and post-approval activities
- Build, mentor, and scale the regulatory affairs team
- Oversee regulatory operations, CMC, and diagnostics functions
- Advise on regulatory due diligence for business development opportunities
Qualifications
- Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field
- 15+ years of regulatory affairs experience in biopharma, with at least 10 years in oncology
- Proven track record leading NDA/BLA/MAA submissions through approval
- Experience with global health authority interactions and late-stage development
- Strong leadership skills with ability to build and manage teams
- Familiarity with electronic submissions (eCTD) and global regulatory frameworks
Why This Opportunity Stands Out
Our client is pioneering therapies that address resistance biology, an area with significant unmet need and market potential. Backed by strong funding, partnerships, and a leadership team with a history of successful oncology approvals, this is a chance to shape the regulatory vision for a company at a major inflection point.
Interested in learning more? Contact us for a confidential discussion.
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