Vice President / Senior Vice President Regulatory Affairs

Vice President / Senior Vice President Regulatory Affairs

This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$300,000.00 / yr - $425,000.00 / yr

Direct message the job poster from EPM Scientific

Recruitment Consultant at EPM Scientific | Building the teams behind the next breakthroughs in healthcare

Senior Vice President / Vice President, Regulatory Affairs

About

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.

Seniority level

Executive

Employment type

Full-time

Job function

Management

Industries

Biotechnology Research and Pharmaceutical Manufacturing

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