Business Head at K.K. Consulting Services
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Senior Executive - Regulatory Affairs - Pharma (3-6 yrs)
Job 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 Applicant's 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 guidelines and update with the current guidelines.
Experience : 4-5 years
Job location : Thane
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