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Senior Advisor / Director, Global Regulatory Affairs CMC
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Full-time
- The Senior Advisor/Director in Global Regulatory Affairs – CMC will leverage CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for clinical trials and marketing authorizations for the synthetic molecule portfolio, including small molecules, peptides, and oligonucleotides.
- Key responsibilities: Deep technical knowledge of synthetic molecule CMC drug development science(s).
- Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations.
- Leads preparation, review, and finalization of CMC documents for global CTA and registration submissions and response to questions.
- Makes decisions on CMC regulatory strategies impacting product submissions across geographies and networks for alignment with CMC team members.
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