Executive - Regulatory Affairs (API Business)

RPG Life Sciences

8 - 10 years

6 - 8 Lacs

navi mumbai

Posted:9 hours ago| Platform:

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Skills Required

regulatory affairs asmf qms dmf ectd ctd api

Work Mode

Work from Office

Job Type

Full Time

Job Description

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.

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