Teva Pharmaceuticals, a global leader in generic medicines and regulatory affairs, is hiring Regulatory Affairs Associate I and Regulatory Affairs Associate II roles in Navi Mumbai. These positions offer strong career growth in eCTD publishing, ANDA lifecycle management, and post-approval regulatory submissions across US, EU, and Canada markets.
If you hold a B.Pharm/M.Pharm/Life Sciences degree and want to advance your career in Regulatory Affairs, this is an excellent opportunity to join a world-class organization with a strong global footprint.
1. Regulatory Affairs Associate I – Job Overview
Key Responsibilities
- Publish and dispatch major and complex eCTD submissions for EU, US, and Canada.
- Manage post-approval submissions, ensuring high-quality and on-time delivery.
- Perform document-level publishing, troubleshooting issues and ensuring compliance with agency guidelines.
- Collaborate with scientific teams for planning, reviewing, and publishing regulatory documents.
- Maintain strong working knowledge of ICH guidelines, eCTD/NeeS, and global regulatory standards.
- Work on regulatory systems including Global Insight, Veeva Vault, Lorenz Validator, ISI Toolbox, Adobe Acrobat.
Qualifications
- B.Pharm/M.Pharm/Master’s in Life Sciences.
- 1–3 years of experience (Regulatory Publishing preferred: US/EU).
- Strong English communication skills.
- Familiarity with regulatory IT systems.
2. Regulatory Affairs Associate II – Job Overview
Key Responsibilities
- Prepare, review, and submit high-quality regulatory submissions to the US FDA.
- Independently manage ANDA annual reports, supplements, and post-approval submissions.
- Evaluate change controls (CC) and ensure compliance with FDA regulations.
- Maintain RA databases and trackers in real time.
- Train Associate I team members on RA processes and documentation.
- Support continuous improvement and regulatory excellence initiatives.
Qualifications
- M.Pharm (RA/QA preferred).
- Minimum 4+ years of experience in Regulatory/QA/analytical or related pharma operations.
- Strong communication, time management, and documentation skills.
- Ability to work independently with minimal supervision.
Why Join Teva Pharmaceuticals?
- Work with the world’s largest generic pharmaceutical manufacturer.
- Exposure to global regulatory frameworks (FDA, EMA, Health Canada).
- Excellent career development in Regulatory Affairs & Submissions Management.
- Inclusive work culture with equal employment opportunity principles.
How to Apply
Interested candidates can apply directly through Teva’s official careers page by searching the Job IDs:
Application Link For – Regulatory Affairs Associate I
Application Link For – Regulatory Affairs Associate II
