Head of Regulatory Affairs

We are supporting a pioneering global pharmaceutical company in the search for a Head of Regulatory Affairs to lead regulatory strategy and compliance across their Massachusetts operations.

This is a critical leadership role, offering the opportunity to shape the development and lifecycle management of a dynamic portfolio of biologic products.

The successful candidate will bring deep expertise in biologics, a strong track record of successful BLA submissions, and the ability to lead and inspire a high-performing regulatory team.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies from IND through to BLA and post-approval stages.
• Lead the Regulatory Affairs team, fostering growth, collaboration, and operational excellence.
• Partner cross-functionally with R&D, Manufacturing, Quality, and Commercial functions to ensure aligned regulatory strategies.
• Oversee the preparation and submission of high-quality BLAs, including supplements and post-marketing updates.
• Ensure compliance with FDA and global regulatory requirements
• Address regulatory challenges and Complete Response Letters through strategic, timely solutions.
• Act as the primary point of contact with FDA and other regulatory agencies for manufactured products.
• Lead interactions and formal meetings with regulatory authorities (pre-IND, end of Phase 2, pre-BLA, etc.).
• Lead regulatory risk assessments across development and marketed products.
• Manage regulatory strategies for product changes, new indications, and ongoing lifecycle activities.
• Monitor and respond to changes in the regulatory landscape that may impact the organization’s operations or products.

Experience

• Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical/biotech sector, including 8+ years in leadership roles.
• Proven success in leading BLA submissions and interactions with FDA.
• Experience in biologics regulatory strategy, including CMC, GMP, and post-approval activities.

Technical Competencies

• Deep knowledge of US and global regulatory requirements for biological products.
• Proficiency with electronic submission systems (eCTD) and regulatory documentation.
• Strong understanding of clinical development, CMC requirements, and GMP compliance for biologics.

Leadership & Education

• Advanced degree (PhD, MSc, or equivalent) in Life Sciences or Regulatory Affairs.
• Excellent strategic thinking, communication, and team leadership capabilities.