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 recent 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 recent 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.