USV - Senior Manager - Regulatory Affairs

- 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

- Min exp of 8 years in Regulatory filings for sterile products.

- Will have a team of 3 to 4 members