Qualification : M.Pharm /B.Pharm/M.Sc. having 8+ years experience in US market
Job profile:
- Responsible for the designated regulatory projects with respective deadlines
- Expertise in authoring CMC documentation for ANDA filings and all post-approval submissions
- Valuable coordination skills with stakeholders on regular basis to source the documents in accordance with project timelines
- Review the documents against the FDA guidances assuring regulatory compliance
- Keep knowledge up to date with regard to regulatory guidelines
- Manage administration of regulatory documentation and ensure the traceability of regulatory history (filing, archiving, database etc)
📌 Asst. Manager/ Sr.Exexcutive (India)
🏢 Centaur Pharmaceuticals
📍 India
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