Manager Biologics-RA-CMC - (EU & US)

About USV Private Limited: USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries Function: Biologics Position: Manager - Regulatory Affairs (CMC)-EU & US markets Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off)) Desired Qualification: M.Pharm/B.Pharm Desired Work Experience: 5-10 yearsCandidate should be from Biologics / Biosimilars Regulatory support and review for pre-filing and development documentation for EU and US. Coordination with internal and external stakeholders for regulatory filing related documentation for EU and US. Review, compilation and authoring of Sterility Assurance and Sterile Process Validation for EU and US. Review of plant and R&D documentation such as BMR, BPR, Specifications etc Authoring, compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier for EU and US. Post approval filing such as supplement and annual report

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