SVP, Global Regulatory Affairs — Biotech Leader

Cornerstone Search Group; Cambridge (MA); On-site; USD 300,000 - 420,000; Full time

Job summary

Cornerstone Search Group is representing a novel biotechnology client seeking a Senior Vice President, Regulatory Affairs to lead global regulatory operations from clinical development to potential market approval. The role reports to the CMO and interacts with the Board on strategy and risk as the senior regulatory voice.

The ideal candidate will drive regulatory strategy for multiple programs, build a high-performing team, and shape the organization toward a registration-stage and

Qualifications

• 15+ years of progressive Regulatory Affairs experience in biotech/pharma.
• Experience leading regulatory strategy from IND to NDA/BLA or MAA submissions.
• Direct interaction with FDA and major global health authorities.

Responsibilities

• Define global regulatory strategy across pipeline from clinical to potential marketing applications.
• Lead critical meetings with FDA and global health authorities.
• Provide strategic leadership for INDs, CTAs, NDA/BLA, and international filings.
• Build and lead a scalable Regulatory Affairs organization.
• Align regulatory strategy with development plans across functions (Clinical, CMC, Quality, Pharmacovigilance).
• Guide partnered development programs and governance with collaborators.

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional collaboration

Executive communication

Job description

Cornerstone Search Group is representing a novel biotechnology client seeking a Senior Vice President, Regulatory Affairs to lead global regulatory operations from clinical development to potential market approval. The role reports to the CMO and interacts with the Board on strategy and risk as the senior regulatory voice.

The ideal candidate will drive regulatory strategy for multiple programs, build a high-performing team, and shape the organization toward a registration-stage and