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Job type
Full-time
Work mode
Hybrid
Level
Director
Department
Other
Experience
10+ years experience
Posted
Sep 11, 2026
About the role
Key Responsibilities
Develop, lead, and execute global CMC regulatory strategies across commercial products and development-stage programs, with primary accountability for late-stage development and post-approval lifecycle management activities.
Provide strategic regulatory leadership to cross-functional teams, influencing development and manufacturing strategies, identifying regulatory risks and opportunities, and driving effective mitigation and contingency plans to support program objectives.
Serve as the primary Regulatory CMC representative on cross-functional program teams and governance committees, ensuring alignment of regulatory strategies with corporate and portfolio goals.
Lead and coordinate regulatory CMC planning, preparation of submissions, and interaction with Health Authorities.
Establish and maintain strong partnerships with internal stakeholders and external collaborators to ensure effective execution of regulatory objectives.
Drive continuous improvement initiatives within the Regulatory CMC function, including development of regulatory processes, best practices, and knowledge management to enhance organizational effectiveness and compliance.
Guide and support junior staff as applicable.
Requirements
Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or related discipline.
10+ years of biotechnology or pharmaceutical industry experience.
7+ years of Regulatory CMC experience supporting biologics, cell and gene therapy. Direct experience with CAR-T cell therapies is desired.
Strong CMC technical background is required. Ability to critically evaluate data from a broad range of scientific disciplines.
Demonstrated experience leading late-stage programs and post-approval Regulatory CMC experience supporting commercial products, including lifecycle management, supplements, variations, annual reports, and post-approval commitments.
Demonstrated global CMC regulatory experience.
Deep understanding of global CMC requirements on cell and gene therapy.
Expertise in late-stage development and lifecycle management.
Strong leadership, strategic thinking, communication, and technical writing skills.
