Experience
5 - 7 yrs
Job Location
Visakhapatnam, India
Vacancy
1
Designation
Senior Executive Regulatory Affairs
Job Type
Not specified
Job Description
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.
No Referrers Available
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