Regulatory Affairs - API ( Jr. Executive/Executive/Sr. Executive ) Biophore

2.0 - 7.0 years

3 - 7 Lacs

Hyderabad

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

Posted 6 hours ago

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