Experience: 15 – 20 Years Qualification: M Pharm., M.Sc. – Chemistry, B.Sc. – Chemistry, B.

Pharm Brief

Preparation and Submission of the dossiers for domestic (CDSCO) and export market (Asian/African/LATAM/CIS) as per the latest guidelines.

Preparation and submission of dossiers for EU/South Africa/UK/Brazil and regulated markets is desirable.

Review of dossiers as per regulatory guidelines to ensure speedy registration and approval.

Review of source documents and data like BMR, BPR, PV, AMV, Analytical data, stability data, DMF, etc.

Handling the queries of the respective markets sent by local representatives OR the regulatory body of that country.

Collection, review and collating the data required for regulatory submissions.

Maintaining the life cycle of the product.

Review of Artworks and preparation of Package insert, SmPC, PIL of Generics with respect to Innovator information and guidelines.

Preparation and review of pharmacovigilance documentation like PSUR, RMP, PMF, etc.

Responding to requests from Internal teams like marketing Domestic and International marketing. Maintaining tracker sheets for regulatory status (Registration, submission and targeted submission, etc.) updated up to the date.

📌 General Manager/ Asst. General Manager - Regulatory Affairs (Formulations) (Mumbai)
🏢 Kopran
📍 Mumbai