Executive Director, Regulatory Affairs

About the Role:

A pioneering biotech company focused on cell and exosome-based therapeutics is seeking an accomplished Executive Director of Regulatory Affairs to lead global regulatory strategy and execution across development programs. This individual will report to the C-suite and play a critical role in shaping regulatory pathways for novel biologics and advanced therapeutics, including late-stage clinical assets.

​

Key Responsibilities:

• Lead the development and implementation of global regulatory strategies for cell and gene therapeutics, including INDs, BLAs, and meeting packages
• Oversee all regulatory submissions and interactions with FDA, EMA, and other global health authorities
• Serve as the primary regulatory contact for internal stakeholders and regulatory agencies
• Ensure regulatory compliance across clinical trial operations, manufacturing, and CMC activities
• Collaborate with cross-functional teams (Clinical, CMC, Quality, Legal) to support regulatory deliverables and timelines
• Manage and mentor a small, high-performing regulatory team and external consultants
• Monitor evolving regulatory landscapes for ATMPs, cell therapies, and biologics, advising internal teams on risks and opportunities

​

Qualifications:

• Advanced degree (PhD, PharmD, or MS preferred) in life sciences or a related field
• Minimum of 12+ years of regulatory affairs experience in the biopharmaceutical industry, with at least 5 years in a leadership role
• Proven success leading regulatory strategy for novel biologics or advanced therapeutics, ideally including cell and gene therapies 
• Experience interfacing with FDA (pre-IND, Type B meetings, Fast Track, RMAT) and authoring INDs, CTAs, and marketing applications
• In-depth understanding of regulatory requirements for CMC, nonclinical, and clinical development
• Demonstrated ability to operate in a fast-paced, resource-conscious environment and influence senior decision-making