Walk-in || Regulatory Affairs Executive At Pharmazone
Time and Venue
- 16th August – 21st August , 9.30 AM – 5.30 PM
- Pharmazone, 401 Safalya Elegance, Science City Road, Sola (View on map)
- Contact – HR Team ( 9512540023 )
Education PG: M.Pharma in Any Specialization-2 – 6 years
Job description
- Providing the support to regulatory affairs team at Pharmazone as Senior Executive.
- Timelines management and delivery of the project.
- Looking after Documentation of the regulatory affairs department.
- Technical review of documents of products received from client for registration purpose.
- Undergoing Gap analysis of documents/data required for dossier preparation.
- Drafting and review of dossier for drug substance, drug product and administrative sections
- To update regulatory guidelines knowledge database regularly.
- Work together with cross-functional teams to ensure regulatory requirements are met throughout the dossier submission and product lifecycle management
- Prepare & review the responses for deficiency letters received from health authorities during the evaluation of marketing authorization/drug registration procedures.
- Perform regulatory submission procedures for US (ANDA), Europe, and other ROW markets.
