Manager Biologics-RA-CMC

4 weeks 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 eCTD format, followed by publishing, validation and submission of dossier for EU and US.
  • Post approval filing such as supplement and annual report

  • Manager biologics-ra-cmc

    4 weeks 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:...

  • Manager Biologics-RA-CMC

    4 weeks 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:...

  • Manager Biologics-RA-CMC

    4 weeks 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 countriesFunction: BiologicsPosition: Manager - Regulatory Affairs (CMC)-EU & US marketsJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))Desired Qualification:...

  • Manager Biologics-RA-CMC

    4 weeks 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:...

  • Manager Biologics-RA-CMC

    3 weeks 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:...

  • Manager Biologics-RA-CMC

    3 weeks 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 countriesFunction: BiologicsPosition: Manager - Regulatory Affairs (CMC)-EU & US marketsJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))Desired Qualification:...

  • Manager Biologics-RA-CMC

    4 weeks 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 countriesFunction: BiologicsPosition: Manager - Regulatory Affairs (CMC)-EU & US marketsJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))Desired Qualification:...

  • Manager Biologics-RA-CMC

    4 weeks 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:...

  • Manager Biologics-RA-CMC

    4 weeks 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 countriesFunction: BiologicsPosition: Manager - Regulatory Affairs (CMC)-EU & US marketsJob Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))Desired Qualification:...

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