Manager Complex Gx Regulatory Affairs jobs at Teva in India, Bengaluru
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India
Bengaluru
20 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...
Process Optimization: Facilitate VSM/Kaizen events, streamline processes to eliminate waste, improve efficiency, and enhance overall performance. Drive Continuous Improvement projects at org level. Collaborate with Functional teams to drive automations/BOTs....
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...
Collaborate with stakeholders to identify business requirements and provide SAP solutions to meet their requirements. Configure and implement SAP CO modules and solutions, (Cost Center accounting / Profit Center Accounting...
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...
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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