Job Title: Regulatory Affairs Associate II
📅 Date Posted: October 1, 2025
📍 Location: Bangalore, India – 560064
🏢 Company: Teva Pharmaceuticals
🆔 Job ID: 62833
🌍 About Teva Pharmaceuticals
At Teva Pharmaceuticals, we are driven by a clear and meaningful mission:
To make good health more affordable and accessible — helping millions of people worldwide enjoy healthier lives.
As the world’s leading manufacturer of generic medicines, Teva proudly produces many products featured on the World Health Organization’s Essential Medicines List.
Operating across nearly 60 countries, our diverse global workforce unites behind innovation, quality, and patient well-being. Each day, more than 200 million people take one of our medicines — and we’re always seeking new ways to make a difference, together.
💡 The Opportunity
We are seeking a Regulatory Affairs Labeling Associate (Associate II level) to support Canadian regulatory labeling activities.
This position requires a detail-oriented, proactive, and self-driven individual with a deep understanding of Health Canada labeling regulations. The role involves end-to-end management of product monograph (PM) updates, bilingual labeling, safety update alignment, and regulatory compliance across systems and teams.
You will work with minimal supervision, ensuring timely, accurate, and compliant labeling activities that meet Teva’s high standards of quality.
🧭 Key Responsibilities
📆 Health Canada Safety Monitoring
Conduct monthly reviews of Health Canada brand safety updates.
Align updates with internal product portfolios and communicate relevant changes to cross-functional stakeholders.
Strategize and implement multi-document labeling updates based on regulatory changes.
📘 Product Monograph (PM) Management
Retrieve the latest innovator PMs from the Health Canada Drug Product Database.
Create and update Teva PMs by referencing Canadian innovator products.
Use TVT (Text Verification Tool) for document comparison to ensure compliance with Health Canada master templates.
Perform QC checks, editing, formatting, and coordinate reviews for management approval.
Collaborate with French translators to develop bilingual PMs.
🏷️ Labeling & Artwork Coordination
Coordinate with the artwork team to develop packaging components (Inserts, Outserts, Cartons, Labels) for sANDS submissions.
Manage the Veeva Artwork Process to obtain final approved artworks.
Conduct quality reviews of labeling and submission documents using manual proofreading and electronic tools (TVT).
🧩 Regulatory Submissions & Compliance
Support Level III safety updates and regulatory commitments with the RA Canada team.
Address Health Canada queries, including:
Clarifaxes
Screening acceptances
Pause-the-clock requests
Extensions
BA/BE (Bioavailability/Bioequivalence) queries
Withdrawals
Ensure timely, eCTD-compliant submissions in collaboration with Regulatory Operations.
Stay updated with the latest Health Canada regulations, guidelines, and SOPs.
📊 Tracking & Documentation
Maintain accurate project trackers to manage due dates, priorities, and timelines.
Keep databases updated with current PMs and share relevant details with internal/external stakeholders.
Support safety-related submissions, including Advisement Letters and Level III changes.
🤝 Collaboration & Continuous Improvement
Work effectively within a team environment while maintaining independence.
Participate in continuous process improvements and additional duties as required by management.
🎓 Education & Qualifications
Required:
Graduate or Postgraduate degree in Pharmacy or Life Sciences (Scientific/Regulatory background preferred).
Preferred:
Advanced qualifications in Regulatory Affairs or Pharmaceutical Sciences.
💼 Experience
Minimum: 3+ years in Regulatory Affairs, specifically in Canadian labeling.
Strong knowledge of:
Health Canada labeling requirements
XML/SPM development
eCTD submission standards
Health Canada guidelines and processes
🧠 Skills & Competencies
Deep understanding of Health Canada regulations and labeling standards.
Proficiency in tools like TVT, Veeva Vault, and publishing software.
Excellent attention to detail, quality mindset, and time management.
Strong written and verbal communication skills.
Ability to multi-task, prioritize, and work independently with minimal supervision.
Strong collaboration and coordination skills across cross-functional teams.
🧑🤝🧑 Internal Applicants
If you’re a current Teva employee, please apply via the Internal Career Site (Employee Central) for priority consideration.
You can also access the portal from your home network.
If you experience any login issues, please contact your local HR or IT partner.
🌈 Equal Employment Opportunity (EEO) Commitment
Teva Pharmaceuticals is an Equal Opportunity Employer, committed to building a diverse, inclusive, and accessible workplace for all.
Employment decisions are made without regard to:
Age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any legally protected status.
If you require accommodations during the recruitment and selection process, please inform us. All information will remain confidential and used solely to provide an inclusive candidate experience.
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