Senior Director Regulatory CMC

Position Overview

Our client, an innovative and fast-growing biopharmaceutical company based in Cambridge, is seeking a Senior Director, Regulatory CMC to lead global Chemistry, Manufacturing & Controls (CMC) regulatory strategy across a dynamic development and commercial portfolio.

This leader will be responsible for designing and executing global CMC regulatory strategies, overseeing all CMC submissions, and leading key health authority interactions. The role requires deep scientific expertise, exceptional strategic judgement, and the ability to partner effectively across CMC, Technical Operations, Quality, Supply Chain, and Program Leadership.

This is a high-visibility, onsite leadership role with significant influence over technical development and regulatory direction.

Key Responsibilities

Strategic CMC Regulatory Leadership

• Develop and own the global CMC regulatory strategy for assigned programs from early development through commercial lifecycle.
• Provide expert guidance on CMC regulatory requirements, precedents, and evolving global expectations.
• Ensure strategic alignment with corporate objectives, development plans, and commercialization goals.

Regulatory Execution & Submissions

• Lead the preparation, authoring, and review of CMC modules (Module 3, Quality Overall Summary, regional requirements).
• Oversee regulatory content for INDs/IMPDs, BLAs/NDAs/MAAs, supplements, variations, and global post-approval changes.
• Drive regulatory risk assessments and propose mitigation strategies for technical and operational challenges.

Agency Engagement & Communications

• Serve as a primary company representative in interactions with FDA, EMA, and other global authorities.
• Strategically plan and lead key regulatory meetings, including Scientific Advice, Type B/C meetings, and pre-approval discussions.
• Manage responses to health authority questions with scientific, high-quality, and timely communication.

Cross-Functional Integration

• Collaborate closely with Process Development, Manufacturing, Quality Assurance, Analytical Development, Supply Chain, and Program Leadership.
• Provide regulatory input into process changes, technology transfers, comparability, control strategies, and analytical plans.
• Support inspection readiness and post-inspection regulatory follow-up where applicable.

Leadership & Team Development

• Lead, mentor, and develop a team of Regulatory CMC professionals (Directors, Managers, Strategists).
• Foster a culture of excellence, accountability, and proactive regulatory intelligence.
• Establish best practices, operating procedures, and standards for high-quality regulatory deliverables.

Qualifications

Education

• Advanced degree preferred (Ph.D., Pharm.D., M.S.) in Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline.
• Bachelor’s degree with extensive relevant experience will be considered.

Experience

• 12–18 years of progressive experience in Regulatory CMC or CMC development within the biopharmaceutical industry.
• 8 years in leadership roles overseeing CMC regulatory strategy and submissions.
• Demonstrated success leading major regulatory submissions (e.g., IND/IMPD, BLA/NDA, MAA).
• Experience with complex modalities such as biologics, mRNA, cell/gene therapy, or viral vector products is strongly preferred.
• Strong track record interacting with U.S. and global regulatory authorities.
• Experience supporting commercial products and post-approval lifecycle management is a plus.

Skills & Competencies

• Deep knowledge of global CMC regulatory requirements and ICH guidelines.
• Ability to translate complex technical CMC content into clear regulatory strategies.
• Strong leadership presence with the ability to influence across all levels.
• Highly collaborative, solutions-oriented, and comfortable working in fast-paced, growing organizations.
• Exceptional written and verbal communication skills.

Additional Details

• Work Model: Onsite in Cambridge; executive presence and engagement with technical teams are essential.
• Travel: Occasional domestic and international travel for agency meetings or partner engagements.
• Compensation: Competitive senior-leadership package including salary, bonus, equity, and benefits.