Manager Complex Gx Regulatory Affairs jobs at Teva in India, Bengaluru
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India
Bengaluru
25 jobs found
08.10.2025
T
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...
Act as the dedicated innovation partner to BU champions, guiding them in engaging stakeholders and surfacing high-quality innovation challenges. Translate BU needs into clear, structured challenge briefs aligned with business...
Primarily works at a project level. Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator’s brochures, health authority responses, and other submission documents (e.g., module 2.5...
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...
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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