Regulatory Affairs Officer Immacule Life Sciences

3 - 6 years

3 - 6 Lacs

Ahmedabad

Work from Office

Roles and Responsibilities Prepare dossiers for regulatory submissions (ANDA) according to US FDA guidelines. Manage CMC sections of ANDA applications, including formulations and OSD products. Coordinate with cross-functional teams for dossier preparation and submission. Ensure compliance with regulatory requirements throughout product lifecycle management. Maintain accurate records and databases related to regulatory affairs activities.

Posted 2 months ago

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