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Associate Director, Complex Gx, Regulatory Affairs Teva Pharmaceuticals

14.0 - 20.0 years

40 - 60 Lacs

bengaluru

Hybrid

Role & responsibilities Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays. Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals. Represent Regulatory Affairs in...

Posted 1 month ago

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