Job Title: Regulatory Affairs Associate II
Date: August 20, 2025
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job ID: 63582
About Us
Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines and the proud producer of many products on the World Health Organization’s Essential Medicines List. Every day, at least 200 million people worldwide take one of our medicines. We operate across nearly 60 countries with a diverse team working together to make healthcare more affordable and accessible.
The Opportunity
As a Regulatory Affairs Associate II, you will:
Prepare, review, and submit high-quality regulatory submissions to the FDA.
Evaluate and process change controls for post-approval changes.
Ensure regulatory and team databases/trackers are updated in real-time.
Take ownership of annual reports, supplements, and post-approval submissions.
Key Responsibilities
Maintain approved ANDA applications in compliance with FDA regulations.
Independently prepare annual reports: request, compile, and publish required documentation for management review.
Work independently on simple supplements and assist on more complex ones under supervision.
Stay updated on FDA post-approval guidance to assess change controls accurately.
Train Associate I team members on internal processes, procedures, databases, and trackers when required.
Support additional projects and duties as assigned.
Qualifications & Experience
Education:
B. Pharmacy / M.Sc. Life Sciences: 4–5 years of industry experience
M. Pharmacy: 3–4 years of industry experience
(Experience in Regulatory, Analytical, QA, Laboratory, or Production preferred)
Skills:
Proficiency in MS Word, Excel, and internet-based tools
Strong verbal and written communication skills
Ability to work independently as well as in teams
Well-organized, detail-oriented, able to multi-task and manage priorities
Why Join Us
Work with a global leader in generics and specialty medicines
Contribute to medicines that impact millions of lives daily
Be part of a diverse, inclusive, and collaborative environment
Equal Employment Opportunity
Teva Pharmaceuticals is committed to providing equal employment opportunities regardless of age, race, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, veteran status, national origin, or any legally protected status. Accommodations will be provided as needed during the recruitment process to ensure accessibility for all candidates.
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