Manager Regulatory Affairs (API) Chinmay Resources - Nalgonda,..R

Manager Regulatory Affairs (API)
Chinmay Resources - Nalgonda, Andhra Pradesh

Experience in DMF preparation in CTDs and Submission in electronic format
Experience in handling and the several regulatory CMC queries for various applications from regulatory authorities and regulatory customer applications.
Knowledge in GMP as per the guidelines and Experience in the initiation, preparation and review of the SOPs, Protocols, APRs, Customer complaints responses, Investigation of deviations etc and all other QA functions.
Co-ordination with various departments and collect inputs required for Regulatory submission.
Submission of DMF’s, Annual updates, Amendments, Revision/renewals etc.,
Reviewing data received from QC, QA, ADL, OSL and make sure that’s compliance
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