Senior Executive - Regulatory Affairs

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.