Walk-In drive- Regulatory Affairs US/EU Aurobindo Pharma

3.0 - 8.0 years

4 - 9 Lacs

hyderabad

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Posted 1 week ago

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Manager, Regulatory Affairs APAC Teva Pharmaceuticals

10.0 - 15.0 years

15 - 20 Lacs

bengaluru

Hybrid

Role & responsibilities Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company. Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases. Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction. Regulatory Submissions Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region. Ensure...

Posted 3 months 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 3 months ago

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