Teva Pharmaceuticals, the world’s leading manufacturer of generic medicines, is hiring a Regulatory Affairs Associate II in Bangalore, India. This role focuses on Canadian regulatory labeling, ensuring compliance with Health Canada guidelines and supporting cross-functional teams with product monograph updates, bilingual labeling, and eCTD submissions.
If you are a pharma graduate with expertise in regulatory affairs, labeling, and Health Canada requirements, this opportunity offers a chance to work with a global healthcare leader impacting millions of lives.
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Key Responsibilities
As a Regulatory Affairs Associate II, you will:
- Review monthly Health Canada brand safety updates and align with internal product lists.
- Strategize labeling changes impacting multiple product documents.
- Retrieve and update product monographs (PMs) using Health Canada Drug Product Database.
- Ensure compliance with HC master templates using tools like TVT.
- Manage bilingual labeling with French translators and coordinate packaging components.
- Conduct proofreading and QC reviews for labeling and submission documents.
- Support Level III safety updates and regulatory commitments.
- Handle Health Canada queries (clarifaxes, BA/BE queries, withdrawals, extensions, etc.).
- Maintain trackers and databases for project timelines and submissions.
- Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations.
- Stay updated with Health Canada regulations, SOPs, and evolving processes.
Qualifications
- Pharma Graduate / Post Graduate in a scientific or regulatory background.
- 3+ years of regulatory affairs experience, specifically in Canadian labeling.
- Strong knowledge of Health Canada labeling requirements.
- Experience with XML/SPM development and Canadian submissions.
- Ability to work independently with minimal supervision.
Benefits of Working at Teva
- Opportunity to work with a global leader in generic medicines.
- Exposure to international Health Canada regulatory frameworks.
- Collaborative and diverse workplace culture.
- Commitment to equal employment opportunity and inclusivity.
How to Apply
