Regulatory Affairs

About V.S. International Private Limited (VSI)

Established in 1997, VSI is a globally focused pharmaceutical company with a growing presence across Africa, Southeast Asia, the Middle East, and Latin America. Operating across branded generics and contract manufacturing, the company is building a diversified and scalable business model.

Our EU-GMP-approved OSD facility in Daman, with accreditations from leading global regulators, supports an annual capacity of 3 billion tablets and 300 million capsules reflecting our strong manufacturing and compliance backbone.

Driven by a robust R&D pipeline and capabilities in complex formulations and advanced drug delivery systems, VSI is focused on expanding its footprint in regulated and semi-regulated markets while strengthening strategic partnerships globally.

Role & responsibilities

1. Preparation and compilation of CTD and ACTD dossiers for Regulated and Emerging Market.

2. Review of Process Validation, Analytical Method Validation, Product Development Records, BMR, BPR, Stability data, Certificate of Analysis etc. required for dossiers.

3. FDA related work- Application of COPP, Legalization of Documents through different embassies, Loan License documentation etc.

4. Co-ordinate with department such as Manufacturing, Product Development, QA/QC,R&D, Legal, Purchase etc. to ensure availability of documents and samples for submission.

5. To develop, check & review Art-works, Labels, and Pack-inserts.

6. Response of queries, Variation Files and other requirements as required by respective regulatory authorities in a stipulated time frame.