Global Regulatory Affairs VP: BLA Strategy & Leadership

ELKA Search Partners; Boston (MA); In loco; USD 260.000 - 360.000; Tempo pieno

Descrizione del lavoro

ELKA Search Partners is seeking a Senior Director or VP of Regulatory Affairs in Boston, MA, to own global regulatory strategy and lead a critical BLA submission through commercialization. Reporting to the CMO, you will serve as the senior regulatory advisor to executive leadership and build the Regulatory function.

You will lead interactions with the FDA and global health authorities, partner with Clinical, CMC, Quality, Pharmacovigilance, Medical Affairs, and Commercial teams, and scale

Competenze

• Advanced degree with 12+ years in regulatory affairs, or bachelor’s with 15+ years.
• 5+ years of progressive Regulatory Affairs leadership.
• Proven track record leading oncology IND and BLA submissions; multiple BLAs preferred.
• Deep understanding of US and global regulatory requirements across clinical development, CMC, quality, and commercialization.
• Experience developing global regulatory strategies and leading FDA, EMA, and other health authority interactions.

Mansioni

• Lead global regulatory strategy across clinical development, BLA submission, approval, and commercialization.
• Own regulatory strategy and cross-functional readiness for the tovecimig BLA, including submission planning, timelines, and FDA engagement.
• Lead INDs, BLAs, amendments, supplements, and other regulatory submissions, ensuring quality and timely delivery.
• Serve as the primary regulatory contact with the FDA, EMA, and other global health authorities.
• Partner cross-functionally with Clinical, CMC, Quality, Pharmacovigilance, Medical Affairs, and Commercial teams.
• Build and scale the Regulatory function, including processes, systems, external partnerships, and team capabilities.
• Advise executive leadership and the Board on regulatory risks, milestones, development strategy, and business decisions.
• Manage regulatory budgets, consultants, vendors, and submission workflows.

Conoscenze

Regulatory leadership

FDA interactions

Cross-functional leadership

Strategic thinking

Budget management

Formazione

Advanced degree in life sciences

Strumenti

Regulatory submission tools

Descrizione del lavoro

ELKA Search Partners is seeking a Senior Director or VP of Regulatory Affairs in Boston, MA, to own global regulatory strategy and lead a critical BLA submission through commercialization. Reporting to the CMO, you will serve as the senior regulatory advisor to executive leadership and build the Regulatory function.

You will lead interactions with the FDA and global health authorities, partner with Clinical, CMC, Quality, Pharmacovigilance, Medical Affairs, and Commercial teams, and scale