Job Title: Head of Regulatory

Work Location: Suffolk County, Massachusetts

Summary:

Seeking an experienced leader to oversee regulatory CMC strategy and execution for programs across all stages of development. This role will provide regulatory guidance, develop strategies, and ensure high-quality submissions in alignment with global requirements.

Responsibilities:

• Direct the creation and management of CMC documentation for global regulatory submissions and address Health Authority inquiries.
• Support authoring and review of amendments related to clinical and commercial manufacturing changes in collaboration with manufacturing and quality teams.
• Utilize technical and regulatory expertise to proactively identify and mitigate risks throughout the development process.
• Act as the primary CMC regulatory representative on cross-functional teams, participating in meetings and providing strategic input.
• Advise technical operations and quality teams to ensure compliance with global product development standards.
• Implement regulatory policies and operational processes to ensure timely and high-quality regulatory submissions.
• Communicate regulatory strategies, risks, and mitigation plans effectively to project teams and senior leadership.
• Foster a collaborative environment, sharing regulatory knowledge and best practices across teams.

Qualifications:

• Minimum of a bachelor’s degree in life sciences required.
• 10+ years of experience in regulatory affairs within clinical stage and/or commercial biotech or pharmaceutical settings.
• Experience with ADC, antibody, protein conjugate, and rare disease programs preferred.
• Comprehensive understanding of FDA guidance, EU regulations, ICH guidelines, and eCTD submissions.
• In-depth knowledge of the drug development process, global regulatory CMC requirements, accelerated review pathways, and policy trends.
• Proven ability to independently manage multiple projects in a fast-paced environment.
• Strong cross-functional collaboration skills to achieve critical regulatory milestones.
• Excellent verbal and written communication skills, including regulatory writing and the ability to convey complex strategies and risks.
• Recognized leadership, teamwork, and collaborative abilities.

Published Category: Regulatory Affairs