15.0 - 20.0 years

0 Lacs

bengaluru, karnataka, india

On-site

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary This position is responsible for leading the Codevelopment products development...

Posted 5 days ago

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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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