Regulatory Affairs Officer

Job Description

Dossier preparation (both ACTD and CTD) and Submission for countries Technical review of documents Co-ordinate with QC, QA departments in plant for that documents and samples required for regulatory submissions. Prepared samples and working standards for courier to clients for registration purpose. Artwork review. co-ordination with client and handle their quires related to product registration. Preparation of apostille documents, Notary legalization Home, IMC (Indian Merchant Chamber) Preparation of Renewals, Variations for the product. Technical review of documents required for Regulatory agencies like DMF, Process validation report and protocol, Analytical method validation report, pharmaceutical development report Stability data, finished product certificate of analysis, finished product specification, Raw material specification, Packaging material specifications etc, Co-ordinate with R and D, QC, QA, ARDL. Departments in plant for that documents and samples required for regulatory submissions. Collect PVSS data from Regulatory Affairs Department and apply for COPP on online FDA site Apply Product license and FSC. Collect Documents and Filing of Tender list. Check applications status on FDA site Job Types: Full-time, Fresher Benefits: Provident Fund Schedule: Day shift Ability to commute/relocate: Mumbai, Maharashtra: Reliably commute or planning to relocate before starting work (Required) Education: Bachelor's (Preferred) Experience: total work: 1 year (Preferred)