VP / SVP Regulatory Affairs

CONFIDENTIAL RETAINED SEARCH | SAN DIEGO LIFE SCIENCES

We are conducting a confidential, retained search for a regulatory affairs vice president (VP or SVP) at a well-established San Diego / CaliBaja life sciences company. The executive will lead global regulatory strategy and serve as the primary interface with the FDA and other health authorities, in partnership with the CMO or CEO. We seek leaders with 15+ years of progressive regulatory affairs experience.

Search Reference: TNF-LS-RA-2026 | Regulatory Leadership Mandate, Life Sciences

ABOUT THIS SEARCH

Top Notch Finders holds an exclusive, strictly confidential retained search for a VP or SVP of Regulatory Affairs. Our client is a clinical-stage to commercial-stage biopharma, oncology, or rare-disease company in the San Diego / CaliBaja life sciences corridor. To protect our client and every candidate, we disclose the company’s identity and the location of its operations only to qualified candidates under a confidentiality agreement. In addition, Top Notch Finders receives and manages every inquiry and application directly.

THE REGULATORY AFFAIRS VICE PRESIDENT OPPORTUNITY

The VP or SVP manages global submission strategy, including IND/CTA, BLA/NDA, and post-marketing filings. As a result, this executive serves as the company’s primary interface with the FDA and other health authorities. In addition, the role advises executive leadership and the board on regulatory risk and submission timelines.

MARKET CONTEXT

Because this search sits in the San Diego / CaliBaja life sciences corridor, cross-border market relevance matters. As a result, EMA and PMDA experience adds real value for this role.

For a deeper look at how we evaluate and hire senior leaders in this industry, read our The 2026 San Diego Life Sciences Executive Search Hiring Guide. It explains our approach to executive search for regulatory and life sciences leadership roles.

KEY RESPONSIBILITIES

• Develop and execute global regulatory strategy across all development-stage and marketed products.
• Lead FDA, EMA, and other health authority interactions, including pre-IND, End-of-Phase 2, and pre-BLA/NDA meetings.
• Oversee the preparation and submission of INDs, BLAs, NDAs, and CTAs.
• Manage post-marketing regulatory compliance, labeling, and lifecycle management.
• Advise executive leadership and the board on regulatory risk and submission timelines.
• Build and manage the regulatory affairs department, including QA/RA integration where applicable.
• Partner with CMC and clinical operations to align regulatory strategy with manufacturing and trial timelines.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• An advanced degree in life sciences, pharmacy, or a related discipline (PharmD, PhD, or MS commonly required).
• 15+ years of progressive regulatory affairs experience in biopharma or medtech.
• Direct experience leading a successful BLA, NDA, or CTA submission and approval.
• Deep knowledge of FDA and international regulatory frameworks; EMA and PMDA experience is a plus.
• Oncology or rare-disease submission pathway experience (strongly preferred).
• Strong cross-functional leadership and executive communication skills.

HOW TO APPLY IN CONFIDENCE

This is a discreet, retained engagement. We will never present your candidacy to any organization without your explicit prior authorization. In addition, the hiring company cannot see any application at this stage.

If you are an accomplished regulatory leader and want to be considered as our next regulatory affairs vice president, please submit your resume in confidence through the Top Notch Finders website. Reference search code TNF-LS-RA-2026 in your submission. However, do not include patient-identifiable information, trial-blinded data, or other confidential clinical information of any kind in your application materials. We will contact only the candidates whose backgrounds align closely with the mandate.