Manager - regulatory affairs

1 week ago

Mumbai, India USV PRIVATE LIMITED Full time
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 years
Candidate 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 e CTD 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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