Vice President Regulatory Affairs

ELKA Search Partners; Boston (MA); Presencial; USD 260 000 - 360 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Regulatory leadership

FDA interactions

Cross-functional leadership

Strategic thinking

Budget management

Formação académica

Advanced degree in life sciences

Ferramentas

Regulatory submission tools

Descrição da oferta de emprego

Senior Director or VP of Regulatory Affairs

Boston, MA - 4 days in office/week

Overview

Seeking an experienced Regulatory Affairs leader to own global regulatory strategy and lead the company through a critical BLA submission and commercialization. Reporting to the CMO, this individual will serve as the senior regulatory advisor to executive leadership, build the Regulatory function, and drive successful interactions with the FDA and other global health authorities.

Key Responsibilities

• 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.

Qualifications

• Advanced degree with 12+ years of relevant industry experience, or bachelor's degree with 15+ years.
• 5+ years of progressive Regulatory Affairs leadership, ideally within a small biotech.
• Proven track record leading successful oncology IND and BLA submissions; multiple successful BLAs strongly 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.
• Demonstrated ability to build regulatory capabilities, lead cross-functional teams, manage complex timelines, and advise executive leadership.
• Strong strategic thinking, business judgment, communication, and stakeholder management skills.