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Associate II, Complex Gx, Regulatory Affairs Teva Pharmaceuticals

4.0 - 8.0 years

0 Lacs

bangalore, karnataka

On-site

As an Associate II in Complex Gx, Regulatory Affairs at Teva Pharmaceuticals, you will be responsible for the preparation and submission of high-quality regulatory filings for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex generic products. Your role will involve managing regulatory submissions, collaborating with cross-functional teams, evaluating change controls, and submitting post-approval supplements in accordance with FDA guidelines and internal SOPs. Additionally, you may serve as a regulatory point of contact for assigned products and contribute to process improvement initiatives. Key Responsibilities: - Prepare, review, and compile new submis...

Posted 1 week ago

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