Role OverviewThe Director, Regulatory CMC will provide strategic leadership for global Chemistry, Manufacturing, and Controls (CMC) regulatory activities across a portfolio of small molecules and monoclonal antibodies.
What You Will Do
Develop and execute global CMC regulatory strategies to support clinical development, product approvals, and ongoing regulatory compliance across commercial markets.
Why It Might Be a Fit
The successful candidate will combine strong scientific expertise, regulatory insight, and exceptional communication skills to drive regulatory success throughout the product lifecycle, from early development through commercialization.
Requirements
- BS or MS degree in Chemistry, Biology, Pharmacy, or a related scientific discipline
- Minimum of 10 years of biopharmaceutical industry experience
- Proven experience supporting at least one major marketing application through preparation, submission, review, and approval
- Strong working knowledge of GMP regulations, ICH guidelines, and global regulatory frameworks
- Deep expertise across both small molecule and monoclonal antibody development programs
- Ability to interpret complex scientific and technical data
- Comprehensive understanding of FDA, EMA, ICH, and other international regulatory requirements
- Excellent communication, presentation, and stakeholder management skills
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