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
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