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| Job Location | Mumbai City |
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Sr Executive - Regulatory APISr Executive - Regulatory API4.0 Year(s) To 5.0 Year(s)Job ProfileJob description for API Regulatory:Preparation, review and submission of Drug Master Files/ CEP in eCTD format for the regions US, EU through ESG and CESP.Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates).Preparation, review and submission of Applicants Part DMF (Open Part DMF) and Technical data package to customers.Handling of DMF deficiencies received from regulatory agencies with coordination of the cross functional teams within the stipulated time.Handling of customer queries related to DMF / Product.Preparation, review and submission of Letter of authorization / Letter of access (LoA) to regulatory authorities & customers.Review of changes for the DMF filed products w.r.t regulatory point of view.Supporting the regulatory / customer audits.Hands on experience on eCTD guide lines and update with the current guide lines.Experience: 4-5 years,
Keyskills :
clinicalresearch healthcareconsulting eu api dmf research management consulting biotechnology ifecycle annualrep customeraudits regulat yagencies cep pharma access clinical healthcare regulat preparation