Regulatory Affairs Associate III
Company: Teva Pharmaceuticals
Location: Navi Mumbai, Maharashtra, India (400706)
Employment Type: Full-Time
Functional Area: Regulatory Affairs
Industry: Pharmaceuticals / Generics
Experience Required: 5+ Years (Pharmaceutical Regulatory Affairs or Related Functions)
Job ID: 64200
Posting Date: November 28, 2025
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, operating in nearly 60 countries worldwide. Every day, over 200 million people rely on Teva medicines, including many products listed on the World Health Organization’s Essential Medicines List. Teva’s mission is to make quality healthcare more affordable and accessible, supported by a diverse, inclusive, and globally connected workforce.
Role Overview
The Regulatory Affairs Associate III plays a critical role in the preparation, review, and submission of high-quality regulatory filings to the US FDA, ensuring compliance with regulatory standards and internal timelines. This position requires the ability to work independently with minimal supervision, manage post-approval regulatory activities, and support the training and development of junior regulatory professionals.
Key Responsibilities
Maintain approved ANDA applications in compliance with FDA regulations, including preparation of Annual Reports
Independently request, compile, finalize, and publish documentation for Annual Reports for management review and FDA submission
Prepare and manage post-approval supplements, ensuring accuracy, completeness, and right-first-time submissions
Evaluate and process Change Controls (CCs) related to post-approval changes, ensuring regulatory compliance
Proactively engage with internal stakeholders to obtain clarity on complex regulatory changes and submissions
Monitor and update regulatory databases, trackers, and internal systems to reflect accurate submission status
Assist regulatory management by training and mentoring Associate I and Associate II team members
Support process improvement initiatives and participate in additional regulatory projects as assigned
Required Experience & Qualifications
Master of Pharmacy (M.Pharm) in Regulatory Affairs or Quality Assurance is preferred
Minimum 5+ years of experience in the pharmaceutical industry, with exposure to:
Regulatory Affairs
Quality Assurance
Analytical or Laboratory Operations
Manufacturing or Production environments
Strong working knowledge of ICH guidelines and US FDA regulations
Proven ability to evaluate regulatory documents and determine appropriate regulatory actions
Excellent written and verbal communication skills
Strong organizational skills with the ability to manage multiple priorities and meet strict timelines
High attention to detail with strong critical and analytical thinking capabilities
Why Join Teva
Work with one of the world’s largest generic pharmaceutical companies
Exposure to global regulatory submissions and FDA interactions
Opportunity to mentor junior professionals and grow into senior regulatory leadership roles
Collaborative, inclusive, and innovation-driven work environment
Meaningful contribution to improving global access to essential medicines
Internal Candidates
Current Teva employees are encouraged to apply through the internal career portal via Employee Central, where applications receive priority consideration. Internal applicants can also view opportunities exclusive to Teva employees.
Equal Employment Opportunity Statement
Teva Pharmaceuticals is an Equal Opportunity Employer committed to diversity and inclusion. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, gender identity, veteran status, or any other legally protected status. Reasonable accommodations are available throughout the recruitment process upon request.
Keywords for Search Optimization
Regulatory Affairs Associate III, Pharmaceutical Regulatory Jobs India, ANDA Regulatory Affairs, US FDA Submissions, Post-Approval Regulatory Affairs, ICH Guidelines, Pharma Jobs Navi Mumbai, Regulatory Affairs Careers India
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