Director of Regulatory Affairs CMC
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Job Summary
To drive regulatory strategy and ensure compliance, the full-time remote Director of Regulatory Affairs CMC will manage the preparation of global regulatory filings and provide guidance on Chemistry, Manufacturing, and Controls (CMC) activities for assigned products.
Key responsibilities
- Develop and execute CMC regulatory strategies for Clinical Phase and Commercial Development
- Manage the preparation of high-quality Regulatory CMC submissions including IND, IMPD, BLA, and MAA
- Represent Regulatory CMC in project teams, providing strategic input for successful product development
Required qualifications
- Bachelor's degree in chemistry, pharmacy, engineering, biochemistry, or a related science; Master's degree preferred
- 10 or more years of Regulatory CMC experience or related pharmaceutical industry experience
- Experience in biologics and developing regulatory strategies for complex products
- Thorough knowledge of FDA, EU, and global regulations related to CMC
- Proficiency in Mandarin Chinese (spoken and written) is highly desirable
Complete Job Description
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