Teva Pharmaceuticals
📍 Bangalore, India
🎓 Pharma Graduate / Postgraduate in a scientific or regulatory discipline
💼 3+ years of experience
✅ Verified Job
About the Role
Teva Pharmaceuticals—the world’s leading manufacturer of generic medicines—is seeking a Regulatory Affairs Associate II in Bangalore, India.
This position focuses on Canadian regulatory labeling, ensuring compliance with Health Canada guidelines and supporting cross-functional teams with product monograph updates, bilingual labeling, packaging components, and eCTD submissions.
If you are a pharma professional with expertise in regulatory affairs, labeling, and Canadian submissions, this is an opportunity to contribute to a global healthcare leader that impacts millions of patients worldwide.
Key Responsibilities
As a Regulatory Affairs Associate II, you will:
- Review and assess monthly Health Canada brand safety updates and align them with internal product lists.
- Plan and implement labeling changes impacting multiple product-related documents.
- Retrieve and update Product Monographs (PMs) from the Health Canada Drug Product Database.
- Ensure compliance with Health Canada master templates using tools such as TVT.
- Coordinate bilingual labeling (English/French) with translators and manage packaging components.
- Conduct proofreading, QC checks, and regulatory reviews for labeling and submission documents.
- Support Level III safety updates and regulatory commitments.
- Respond to Health Canada queries (clarifaxes, BA/BE queries, withdrawals, extensions, etc.).
- Maintain trackers, logs, and databases for timelines and submissions.
- Ensure timely eCTD-compliant submissions in collaboration with Regulatory Operations.
- Stay current with Health Canada regulations, SOPs, and evolving regulatory processes.
Qualifications & Skills
- Pharma Graduate / Postgraduate in a scientific or regulatory discipline.
- 3+ years of regulatory affairs experience, with a strong focus on Canadian labeling.
- In-depth understanding of Health Canada regulatory and labeling requirements.
- Hands-on experience with XML/SPM development and Canadian submissions.
- Excellent organizational skills, with the ability to work independently and manage deadlines.
- Strong communication and collaboration skills to work with cross-functional global teams.
Why Join Teva?
- Work with a global leader in generic and specialty medicines.
- Gain international exposure to Health Canada regulatory frameworks.
- Be part of a diverse, collaborative, and innovation-driven workplace culture.
- Contribute to Teva’s mission of improving access to affordable, quality healthcare worldwide.
- Enjoy a supportive environment with career growth and development opportunities.
How to Apply
Apply directly via the [Application Link] provided.
⚡ At Teva, your expertise doesn’t just support compliance—it helps bring essential medicines to patients across the globe.