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Director, Regulatory CMC
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Full-time
- This role will lead and support the CMC strategies and submission including clinical trials applications, marketing applications, agency briefing packages and response to regulatory authority queries.
- Provide CMC expertise in the Editas regulatory affairs organization by keeping abreast of global CMC regulatory requirements and ensure that project team colleagues and management are informed of developments opportunities and risks that may impact regulatory success.
- Accountable for CMC regulatory strategy for assigned portfolio programs, including but not limited to developing regulatory strategy and plan for CMC development, assessing regulatory scenarios risks and opportunities, proposing risk mitigation measures, and, assessing the probability of regulatory success, and proposing risk mitigation measures.
- Accountable for the management and delivery of all CMC regulatory milestones, including global investigational drug filings (e.g., IND / CTA / IMPD / GMO), registrational filings (e.g., BLA, NDS, MAA, and supplements), and responses to health authority questions/requests.
- Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
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