VP / SVP Regulatory Affairs

CONFIDENTIAL RETAINED SEARCH | SAN DIEGO LIFE SCIENCES

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

ABOUT THIS SEARCH

Top Notch Finders has been retained on an exclusive and strictly confidential basis to identify a VP/SVP of Regulatory Affairs for a client in the San Diego / CaliBaja life sciences corridor. To protect the interests of our client and of every candidate who engages with us, the identity of the company is disclosed only to qualified candidates under a confidentiality agreement. All inquiries and applications are received and managed solely by Top Notch Finders.

POSITION SNAPSHOT

• Company profile: Clinical-stage to commercial-stage biopharma, oncology, or rare-disease company.
• Reports to: CMO or CEO.
• Location: San Diego / CaliBaja region; specifics disclosed to qualified candidates.

THE OPPORTUNITY

The VP/SVP of Regulatory Affairs manages global submission strategy, including IND/CTA, BLA/NDA, and post-marketing filings, and serves as the company’s primary interface with FDA and other health authorities.

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 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

• 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 a plus given cross-border market relevance.
• Experience in oncology or rare-disease submission pathways strongly preferred.
• Strong cross-functional leadership and executive communication skills.

CONFIDENTIALITY AND HOW TO APPLY

This is a discreet, retained engagement. Your candidacy will never be presented to any organization without your explicit prior authorization, and no application will be visible to the hiring company at this stage. Accomplished regulatory leaders are invited to submit a resume in confidence through the Top Notch Finders website. Please reference search code TNF-LS-RA-2026 in your submission. Do not include patient-identifiable, trial-blinded, or other confidential clinical information of any kind in your application materials. Only candidates whose backgrounds align closely with the mandate will be contacted.