Zydus Cadila, a leading Indian Pharmaceutical company is a fully integrated, global healthcare provider. With in-depth domain expertise in the field of healthcare, it has strong capabilities across the spectrum of the pharmaceutical value chain.
Post : Assistant Manager / Deputy Manager - Regulatory Affairs (API)
The incumbent should have M.Sc / M.Pharm with 8 to 10 years of relevant experience in API Regulatory Affairs.
Preparation of US DMF, CEP in eCTD and preparation of ASMF. Should have thorough knowledge in ICH and other regulatory guidelines. Thorough knowledge of control strategy is essential. Hands on experience for query response for the relevant competitive authority (US FDA). Review and compilation of data required for regulatory submissions to various regulatory authorities. Response to the customer queries with consultation with Manager Regulatory affairs. Update the knowledge as per recent guidelines to cater the requirement while compilation of regulatory submissions.
Job Location : Vadodara
Interested candidate may apply on firstname.lastname@example.org
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