Assoc Dir Regulatory Affairs jobs at Teva in India, Bengaluru
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India
Bengaluru
15 jobs found
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Teva Regulatory Affairs Associate II India, Karnataka, Bengaluru
Monthly review of Health Canada brand safety updates. Align updates with internal product lists and communicate relevant changes to cross-functional teams. Strategize and implement changes impacting multiple product documents. Track...
Ensure the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) of innovative, biosimilar and generic products. Provide internal pharmaceutical and...
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...
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...
Independently support the preparation, review, and compilation of regulatory submissions (original applications, supplements, and responses) for sterile complex generic products. Support early FDA engagement to align on development strategy, reduce...
The Associate II, Complex Gx, Regulatory Affairs is responsible for the preparation and submission of high-quality regulatory filings—both pre- and post-approval—for U.S. FDA-regulated inhalation, implant, ophthalmic, and drug-device combination complex...
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...
Monthly review of Health Canada brand safety updates. Align updates with internal product lists and communicate relevant changes to cross-functional teams. Strategize and implement changes impacting multiple product documents. Track...
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