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Job Title: Regulatory Affairs(Complex Injectables)
Company: Leading Pharma Company in Hyderabad Location
Designation: Sr Executive to Assistant Manager

No. of Positions: 5

Division: R&D

Department: Regulatory Affairs
Job Location:Hyderabad Location
Qualification: MSc/ M.Pharma

Years of Experience:4 to 7 Years
Salary Range: 10 LPA

Contact person: Mr.Zabi Moghal
Mobile: 7676936384
Email: [email protected]

Job Description:

Preparation of ANDAs/ 505(b)(2) /EU Dossiers/ ANDSs for US, EU & Canada market as per regulatory requirements
Review of master documents and reports (Specifications , PDR, Manufacturing and Packing Batch records, artworks, PVP, PVR, Protocols) for ANDAs/EU Dossiers/ ANDSs and deficiency response

Coordinate with internal CFTs (R&D, AR&D, SCM, API-RA etc) as well as external counterparts (i.e. manufacturing and testing sites etc) as RA SPOC

Preparation of deficiency response. Co-ordinate with CFTs, track the action items and review the documents for deficiency response

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