19/04 Kalyan Karve
Business Head at K.K. Consulting Services

Views:148 Applications:10 Rec. Actions:Recruiter Actions:1

Senior Executive - Regulatory Affairs - Pharma (3-6 yrs)

Thane Job Code: 3106

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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