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Executive/ Senior Executive - 21 CFR Intas

5.0 - 10.0 years

7 - 13 Lacs

ahmedabad

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Regulatory Compliance Ensure full compliance with applicable 21 CFR regulations (including but not limited to 21 CFR Part 210, 211, 312, 314, 820 as applicable). Interpret and implement FDA regulatory requirements across manufacturing, quality, and development functions. Monitor changes in FDA regulations and assess impact on company processes. Documentation & Submissions Review, prepare, and maintain regulatory documents such as SOPs, validation protocols, batch records, and quality manuals . Support preparation and review of IND, NDA, ANDA, DMF, or 510(k) documentation as applicable. Ensure data integrity and document control in line with 21 CFR Part 11 requirements. Quality Systems & Audi...

Posted 7 hours ago

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