About this role
Qualification: M.Sc. / B. Pharm / M. Pharm Experience: 3-4 years Role and
Responsibilities Regulatory Activities
- Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures.
- Experience in handling API drug submissions to regulated markets – Canada, UK, Europe, Brazil, China, Japan, US etc.
- Filing amendments, updates with relevant health agencies Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software Preparation of response to queries received from health authorities and customers Evaluation of regulatory impact and review of QMS documentation Coordination with various stake holders at site for documentation Participation in project review meeting regarding new products and providing regulatory feedback Licensing Activities: Interaction with Licensing authorities Monitor and maintain all valid licenses as per Drug and Cosmetic act.
- 1940 and Rules 45.
- Applications for new licences according to requirements.
- Online applications on NSWS/ SUGAM portal.
- Monitor and maintain all documents as per NDPS act.
- 1985.
- Monitor and maintain Legatrix activities Monitor and maintain Loan Licenses certificate and approvals.