Job Title: Regulatory Affairs Associate II
Job ID: 62833
Posting Date: October 1, 2025
Location: Bangalore, India, 560064
Company: Teva Pharmaceuticals
Company Overview
Teva Pharmaceuticals is a global leader in generic medicines and a proud producer of products on the World Health Organization’s Essential Medicines List. With operations in nearly 60 countries, Teva’s mission is to make health more affordable and accessible, impacting the lives of over 200 million people daily.
Job Overview
The Regulatory Affairs Associate II (Labeling) will support Canadian regulatory labeling activities, ensuring compliance with Health Canada requirements. The role involves monitoring safety updates, creating and updating product monographs, coordinating bilingual labeling, and collaborating with cross-functional teams. The candidate should demonstrate attention to detail, proactivity, and the ability to work with minimal supervision.
Key Responsibilities
Health Canada & Labeling Activities
Conduct monthly reviews of Health Canada brand safety updates.
Align safety updates with internal product lists and communicate changes to cross-functional teams.
Track and retrieve innovator product monographs (PMs) from the Health Canada Drug Product Database.
Create and update Teva PMs referencing Canadian innovator products.
Ensure compliance using tools like TVT for document comparison and HC master templates.
Perform QC, editing, and formatting; coordinate review and approval processes.
Collaborate with French translators for bilingual PMs.
Coordinate with artwork teams for packaging components (inserts, outserts, cartons, labels).
Manage the Veeva Artwork Process to obtain final artworks.
Conduct quality reviews of labeling and submission documents using manual and electronic tools.
Support Level III safety updates and regulatory commitments in collaboration with the Canada RA team.
Address Health Canada queries, including clarifaxes, screening acceptance, pause-the-clock requests, extensions, BA/BE queries, and withdrawals.
Maintain accurate project trackers to monitor due dates, priorities, and timelines.
Share current PMs and relevant details with internal and external stakeholders.
Collaborate with the RA Canada team on safety-related submissions, advisement letters, and Level III changes.
Ensure timely eCTD-compliant submissions in coordination with Regulatory Operations.
General Responsibilities
Stay current with Health Canada regulations, guidelines, and SOPs.
Work effectively in a team environment with minimal supervision.
Perform additional job-related duties as required by management.
Experience & Qualifications
Pharma Graduate/Postgraduate with a scientific or regulatory background, or equivalent combination of education and experience.
Minimum 3 years of experience in Regulatory Affairs with a focus on Canadian labeling.
Knowledge of Health Canada regulatory requirements for labeling.
Familiarity with XML/SPM development and Health Canada requirements.
Equal Opportunity Commitment
Teva Pharmaceuticals is committed to equal employment opportunity, diversity, and an inclusive workplace. Accommodation for candidates requiring support during recruitment and selection will be provided confidentially.
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