Vice President (VP) Regulatory CMC

Position Summary

The Vice President, Regulatory CMC will serve as the senior leader responsible for developing and executing global CMC regulatory strategies across the company’s development and commercial portfolio. This role provides strategic and operational leadership for all CMC regulatory activities—including submissions, major regulatory interactions, and lifecycle management—and partners closely with CMC, Technical Operations, Quality, and Program Leadership to ensure the successful advancement of pipeline and marketed products.

This is an onsite Boston-based executive role with high visibility across the organization and significant engagement with global health authorities.

Key Responsibilities

Strategic Leadership

• Define and lead the global CMC regulatory strategy for all programs from early development through commercialization.
• Serve as the company’s senior expert on CMC regulatory expectations, emerging guidelines, and policy developments across the U.S., EU, and other key regions.
• Provide executive oversight of CMC regulatory deliverables for major filings (IND/IMPD, BLA/NDA/MAA, post-approval changes).
• Represent Regulatory CMC on the Executive Leadership Team and key governance committees.

Regulatory Execution & Oversight

• Direct the preparation, authoring, and quality of CMC sections of regulatory submissions, ensuring scientific rigor and compliance with global standards.
• Oversee CMC regulatory risk assessments, agency interactions, and strategy development for complex technical issues.
• Lead major regulatory meetings with FDA, EMA, and other health authorities, ensuring alignment on CMC strategy and data packages.
• Drive timely and compliant post-approval CMC lifecycle management, including global change controls, supplements, variations, and renewals.

Cross-Functional Collaboration

• Partner closely with Process Development, Manufacturing, Quality, Supply Chain, Clinical, and Program Management to provide integrated CMC regulatory leadership.
• Advise senior technical and business leaders on regulatory implications of process changes, technology transfers, supply strategies, and manufacturing network decisions.
• Ensure CMC regulatory considerations are built into development plans, technical reports, and program milestones.

Team Leadership & Organizational Development

• Lead and develop a high-performing Regulatory CMC organization, including Directors, Strategists, and Managers.
• Establish functional vision, operating model, staffing plans, and performance standards for the CMC regulatory team.
• Foster a culture of accountability, collaboration, scientific excellence, and continuous improvement.

Qualifications

Education

• Advanced degree preferred (Ph.D., Pharm.D., or M.S.) in Chemistry, Pharmaceutical Sciences, Biochemical Engineering, or related life sciences discipline.

Experience

• 15 years of experience in Regulatory Affairs, CMC Regulatory, or CMC functions within the biopharmaceutical industry.
• 10 years in leadership roles, with demonstrated success managing senior regulatory professionals and cross-functional teams.
• Proven track record of leading CMC regulatory strategy for multiple products at various stages (early development through commercial).
• Strong experience interacting with FDA, EMA, and other global agencies, including leading Type B/C, Scientific Advice, and pre-approval meetings.
• Experience with complex modalities strongly preferred (e.g., biologics, antibodies, cell/gene therapy, mRNA, viral vectors).

Skills & Attributes

• Deep understanding of global CMC regulatory frameworks, guidelines, and evolving expectations.
• Executive-level communication skills and ability to influence across technical and non-technical audiences.
• Strategic thinker with strong operational execution skills and a mindset focused on innovation and quality.
• Ability to thrive in a fast-paced, high-growth environment with a hands-on leadership style.
• High integrity, sound judgment, and commitment to compliance.

Additional Information

• Location: Onsite role based in Boston; executive presence required.
• Travel: Occasional domestic and international travel for regulatory meetings, conferences, or partner engagements.
• Compensation: Competitive executive compensation package including salary, bonus, equity, and benefits.