Regulatory Affairs Associate III
Location: Navi Mumbai, Maharashtra, India (400706)
Company: Teva Pharmaceuticals
Job ID: 64200
Employment Type: Full-time
Posted On: December 27, 2025
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making high-quality healthcare more accessible and affordable worldwide. Operating across nearly 60 countries, Teva’s diverse workforce supports millions of patients daily with products listed on the World Health Organization’s Essential Medicines List. Joining Teva means being part of a purpose-driven organization that values innovation, collaboration, and regulatory excellence.
Role Overview
Teva is seeking an experienced Regulatory Affairs Associate III to support U.S. FDA regulatory submissions and post-approval lifecycle management. This role involves independent preparation, review, and submission of ANDA Annual Reports, supplements, and post-approval changes, while ensuring full compliance with FDA and ICH guidelines. The position also includes mentoring junior regulatory professionals and supporting process improvements within the regulatory function.
Key Responsibilities
Maintain approved ANDA applications in compliance with U.S. FDA regulations
Independently prepare, compile, publish, and submit ANDA Annual Reports within regulatory timelines
Proactively request, review, and manage documentation required for regulatory submissions
Prepare and manage supplements and post-approval submissions, ensuring right-first-time quality
Evaluate and process Change Controls (CCs) related to post-approval changes with minimal supervision
Monitor and update regulatory databases, trackers, and submission records accurately
Collaborate with cross-functional teams (QA, Analytical, Manufacturing) to gather submission inputs
Provide regulatory guidance and training to Associate I and Associate II team members
Support management with process improvements and additional regulatory projects as assigned
Process Improvement
Identify opportunities to enhance submission quality, efficiency, and compliance
Contribute to continuous improvement initiatives within the Regulatory Affairs function
Experience Required
Minimum 5+ years of experience in the pharmaceutical industry
Hands-on experience in Regulatory Affairs, FDA submissions, ANDA lifecycle management, or related areas
Prior exposure to post-approval changes, supplements, and annual reports is mandatory
Educational Qualifications
M.Pharm in Regulatory Affairs or Quality Assurance preferred
Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, or related discipline
Skills & Competencies
Strong working knowledge of FDA and ICH guidelines
Proven ability to evaluate regulatory documents and determine appropriate regulatory actions
Excellent written and verbal communication skills
Strong organizational and multitasking abilities with attention to detail
Sound critical thinking and problem-solving skills
Ability to work independently with minimal supervision
Why Join Teva
At Teva, regulatory professionals play a critical role in ensuring timely patient access to essential medicines. The company offers a collaborative work culture, opportunities for professional growth, and exposure to global regulatory environments.
Equal Employment Opportunity
Teva Pharmaceuticals is an equal opportunity employer and is committed to building a diverse and inclusive workplace. Employment decisions are made without regard to age, race, religion, gender, disability, sexual orientation, gender identity, or any other protected status. Reasonable accommodations are available throughout the recruitment process upon request.
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