Senior Manager/Assistant General Manager - Regulatory Affairs - Sterile - ANDA - Pharma

We have a job opening for the position of Senior Mgr/ Asst General Mgr - Regulatory Affairs (Sterile - ANDA)

Designation: Senior Manager/Assistant General Manager - Regulatory Affairs (Sterile - ANDA)

Reporting: Vice President - Regulatory Affairs (ANDA)

Location: Govandi, Mumbai

Qualification: M. Pharm/ B. Pharm with 10 - 12 years experience in sterile formulation filings for US markets

Job description:

- Regulatory support and review for pre-filing and development documentation

- Coordination with internal and external stakeholders for regulatory filing related documentation

- Review, compilation and authoring of Sterility Assurance and Sterile Process Validation

- 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

- Post approval filing such as supplement and annual report

Kirti A.
Research Associate
Phone: 022-41205501|Cell: 7208546422