Associate II, Sterile, Regulatory Affairs Teva Pharmaceuticals

4.0 - 8.0 years

4 - 7 Lacs

bengaluru

Work from Office

Role & responsibilities With moderate to minimal guidance, prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Work with their manager to support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers and alternate API sourcing. On occasion, serve as regulatory contact point for cross-functional teams like R&D, QA, Manufacturing & Packaging sites, DMF holders, etc. Monitor and manage regulatory timelines and proactively address data or document gap...

Posted Date not available

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Associate III, Complex Gx, Regulatory Affairs Teva Pharmaceuticals

6.0 - 11.0 years

6 - 12 Lacs

bengaluru

Work from Office

Role & responsibilities Independently prepare, review, and compile new submissions, deficiency responses (IRs, DRLs, CRLs), and amendments using the "Right-First Time" approach. Support early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Support regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. Lead regulatory discussions with R&D, quality, and manufacturing to resolve data issues and guide regulatory expectations to align on submission readiness and strategies, including global RA alignments. Provide strategic regulatory input and s...

Posted Date not available

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