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CMC Regulatory Affairs Senior Manager Principal Scientist
Job Summary
A company is looking for a CMC Regulatory Affairs Senior Manager Principal Scientist.
Key Responsibilities:
- Participate in the development and execution of Regulatory CMC strategies for gene therapy programs
- Generate CMC-related regulatory documentation and submissions in compliance with regulations
- Assess and communicate CMC regulatory requirements and provide guidance on compliance
Required Qualifications:
- Bachelors or Masters Degree in life science field or related scientific discipline
- 3+ years of experience in Regulatory CMC or related field
- Experience with regulatory submissions and viral vector gene therapy products preferred
- Prior successful filing of IND/CTA and/or BLA/NDA/MAA preferred
- Working knowledge of FDA, EMA, and ICH regulations/guidance
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