Senior Director, Regulatory Affairs Strategy
4 weeks ago
Job Summary
The Senior Director, Regulatory Affairs Strategy will provide strategic leadership for the company's regulatory affairs and novel drug development programs. This role will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and ensuring compliance with ICH and local country regulatory requirements.
Key Responsibilities
- Develop and execute novel drug regulatory strategy
- Ensure development programs are compliant with ICH and local country regulatory requirements
- Lead cross-functional teams to achieve regulatory goals
- Author clear and concise regulatory documents for submissions
- Collaborate with regulatory CMC lead and development team to align regulatory strategy and CMC strategy
Qualifications
- Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering
- 10+ years industry experience in RA novel drug development
- CMC and/or Botanical experience, RAC certification
- Thorough understanding of ICH and US CFR requirements and regulations
- Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs, briefing books)
- Regulatory agency direct interaction experience
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