Job Role
Job RoleGeneral Manager/ Asst. General Manager - Regulatory Affairs (Formulations)
Experience: 15 – 20 Years
Qualification: M Pharm., M.Sc. – Chemistry, B.Sc. – Chemistry, B. Pharm
Brief Job Description:
- 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.
- HO-Worli
- Full Time