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CMC Regulatory Affairs Manager
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- Bachelor's, Master's, or Ph. D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
- 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
- Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
- Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
- Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.
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