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Sr. Director, Regulatory Affairs Strategy
2 months ago
The Senior Director, Global Regulatory Affairs Strategy will provide strategic leadership in regulatory affairs for our company and its innovative drug development programs.
- Develop and implement regulatory strategies for new drug programs
- Ensure compliance with ICH and local regulatory requirements
- Strong project management and interpersonal skills for managing complex programs
- Author clear regulatory documents and oversee submissions
- Collaborate with regulatory CMC lead and development team for alignment
- Act as the regulatory liaison between the company and regulatory agencies
- Master's degree in Chemistry, Biochemistry, Pharmacy, Biomedical Engineering, or Chemical Engineering required; PhD or PharmD preferred
- Minimum of 10 years industry experience in regulatory affairs for new drug development
- Experience with CMC and/or Botanicals, RAC certification
- Proficiency in ICH and US CFR regulations
- Expertise in authoring regulatory documents and interacting with regulatory agencies
- Excellent communication skills