Regulatory Affairs - Required Sr Executive to Assistant Manager
Posted: 01 Jan 2021, 17:11
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
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