Regulatory Affairs Associate Pharma Jobs in Bangalore- Apply Now
Teva Pharmaceuticals is seeking a Regulatory Affairs Associate II in Bangalore to manage Canadian labeling compliance. This full-time role involves Health Canada regulatory updates, product monograph creation, bilingual labeling coordination, and quality review of submission documents, ensuring all processes meet regulatory standards.
About the Company
Teva Pharmaceuticals is a global leader in generic medicines and essential healthcare products. Committed to making health more affordable and accessible, Teva serves millions worldwide, with a diverse workforce spanning nearly 60 countries.
- Position: Regulatory Affairs Associate II
- Location: Bangalore, India
Regulatory Affairs Associate Pharma Jobs- Role Overview
The Regulatory Affairs Associate II will support Canadian regulatory labeling activities, ensuring compliance with Health Canada regulations. The role focuses on monitoring safety updates, managing product monographs, coordinating bilingual labeling, and quality reviewing submission documents.
Regulatory Affairs Associate Pharma Jobs- Key Responsibilities
- Review Health Canada brand safety updates monthly.
- Align updates with internal product lists and communicate changes to cross-functional teams.
- Strategize labeling changes affecting multiple product documents.
- Track and retrieve innovator PMs from the Health Canada Drug Product Database.
- Create and update Teva PMs referencing Canadian innovator products.
- QC, edit, format, and coordinate PM review and approval.
- Collaborate with French translators for bilingual PMs.
- Coordinate artwork creation for packaging components and manage Veeva Artwork Process.
- Conduct quality reviews of labeling documents using manual and electronic tools.
- Address Health Canada queries and support safety-related submissions.
- Maintain accurate project trackers and update regulatory databases.
- Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations.
Qualifications
- Pharma Graduate/Postgraduate with a scientific or regulatory background.
- 3+ years of experience in Regulatory Affairs, focusing on Canadian labeling.
- Knowledge of Health Canada labeling requirements and XML/SPM development.
- Ability to work independently and collaboratively in a team environment.
Why Join Teva
Teva offers a supportive and inclusive work environment, career growth opportunities, and the chance to make a meaningful impact on global healthcare through regulatory excellence.
