Associate Ii Complex Gx Regulatory Affairs jobs at Teva in India, Bengaluru
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India
Bengaluru
24 jobs found
25.08.2025
T
Teva Associate II Complex Gx Regulatory Affairs India, Karnataka, Bengaluru
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...
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...
Develop and Maintain DR Plans: Create, update, and test disaster recovery plans to ensure they are effective and align with business continuity strategies. Define BIA, Recovery Time Objective (RTO) and...
Support business decisions by providing ad hoc costing analytics and assessments for different costing scenarios. Maintain analytical processes, routines and tools to support costing analysis and validation. Support costing queries...
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...
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