Regulatory Affairs Strategy Director
2 days ago
The position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs.
Key Responsibilities- Develop and execute novel drug regulatory strategy
- Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
- Strong project management skills and strong interpersonal skills to handle complex distributed programs
- Ability to author clear and concise regulatory documents with oversight of all documents for regulatory submissions and associated messaging
- Work closely with regulatory CMC lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned
- Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison for the company
- Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering is mandatory; PhD or PharmD in above disciplines are preferred
- 10+ years industry experience a must with 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
- Strong communications skills
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