Director, Global Regulatory Affairs CMC

Director, Global Regulatory Affairs CMC

Cambridge, MA (Hybrid)

About the Job

A leading global biopharmaceutical organization is seeking a Director, Global Regulatory Affairs CMC to provide strategic leadership across the development, registration, and lifecycle management of complex products worldwide. This is a high-impact opportunity for an experienced Regulatory CMC professional who thrives at the intersection of science, strategy, and global regulatory execution.

Key Responsibilities

• Define and execute global Regulatory Affairs CMC strategies to support product development, registration, and lifecycle management activities.
• Serve as the Global Regulatory CMC Lead for assigned programs, providing strategic direction across development through commercialization.
• Lead major global regulatory submissions, including INDs, CTAs, BLAs, MAAs, and post-approval filings.
• Partner closely with cross-functional teams across Regulatory Affairs, Pharmaceutical Development, Manufacturing, Quality, and Commercial functions to drive program success.
• Represent the organization in interactions with global health authorities and support preparation for regulatory meetings and agency responses.
• Identify regulatory risks and opportunities, developing proactive strategies that support successful approvals and ongoing compliance.
• Mentor and influence regulatory team members while providing expert guidance on complex CMC regulatory matters and global submission strategies.

Qualifications

• Advanced scientific degree (MS, PhD, or equivalent)
• 10+ years of biopharmaceutical industry experience
• 8+ years of Regulatory Affairs CMC experience
• Experience leading major global filings, including NDA, BLA, MAA, IND, and CTA submissions
• Deep understanding of global CMC regulations and lifecycle management activities
• Strong leadership, communication, and stakeholder management skills
• Demonstrated success working within complex global organizations