Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making healthcare more affordable and accessible. With a presence in nearly 60 countries, Teva produces many of the medicines listed on the World Health Organization’s Essential Medicines List. Every day, over 200 million people rely on Teva’s medications, reinforcing its mission to improve global health.
Job Description
Teva Pharmaceuticals is hiring a Regulatory Affairs Associate I to join its Regulatory Publishing team in Navi Mumbai. This role ensures high-quality, timely submissions for EU, US, and Canadian markets, supporting post-approval regulatory activities.
Key Responsibilities:
- Publish and dispatch eCTD submissions for regulatory filings (EU, US, Canada).
- Handle post-approval submissions and ensure compliance with agency guidelines.
- Perform document-level publishing, troubleshoot issues, and conduct quality checks.
- Collaborate with scientific teams for submission planning and preparation.
- Maintain knowledge of ICH, eCTD, NeeS, and paper submission guidelines.
- Work with regulatory tools like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, and Lorenz Validator.
Qualifications & Experience:
- B.Pharm, M.Pharm, or Master’s in Life Sciences
- 1–3 years of regulatory publishing experience (preferably in EU/US markets).
- Strong command of English (written & spoken).
- Familiarity with regulatory IT systems and eCTD standards.
- Ability to work in a culturally diverse global organization.
Reports To:
Manager – Regulatory Submission Management
Why Join Teva Pharmaceuticals?
- Work with a global leader in generic medicines.
- Contribute to life-saving medications used by millions.
- Collaborative and inclusive work environment.
- Opportunities for professional growth in regulatory affairs.
