Job Title: Regulatory Affairs Associate III
📅 Date Posted: October 1, 2025
📍 Location: Navi Mumbai, India – 400706
🏢 Company: Teva Pharmaceuticals
🆔 Job ID: 64200
🌍 About Teva Pharmaceuticals
At Teva Pharmaceuticals, we’re united by a single mission:
To make good health more affordable and accessible, helping millions around the world enjoy healthier lives.
As the world’s leading manufacturer of generic medicines, Teva is the proud producer of numerous products listed on the World Health Organization’s Essential Medicines List.
Each day, more than 200 million people rely on Teva medicines. With operations in nearly 60 countries, we embrace diversity, innovation, and collaboration to continue making a meaningful impact on global health.
💡 The Opportunity
The Regulatory Affairs Associate III will independently prepare, review, and submit high-quality regulatory submissions to the U.S. FDA in compliance with company timelines and regulatory requirements.
This role involves evaluating change controls (CCs) related to post-approval changes, ensuring all documentation is accurate, complete, and compliant.
The Associate III will also maintain regulatory databases and trackers, manage Annual Reports, Supplements, and Post-Approval Submissions, and play a key role in mentoring and training junior associates.
🧭 Key Responsibilities
📑 Regulatory Submissions
Prepare, review, and submit regulatory submissions to the FDA in accordance with company timelines and regulatory guidelines.
Maintain approved ANDA applications in full compliance with FDA regulations.
Independently collect documentation required for Annual Reports, compile and finalize them for management review and submission to the Agency.
Prepare supplements, take a proactive approach to complex submissions, and collaborate with internal stakeholders to ensure accuracy and completeness.
Deliver right-first-time submissions by ensuring all information is comprehensive and compliant.
🔄 Change Control Management
Independently evaluate Change Controls (CCs) intended for post-approval modifications.
Ensure completeness, accuracy, and compliance of CCs, and progress them promptly in the absence of comments.
📊 Database & Tracker Management
Monitor and maintain regulatory databases and trackers, ensuring they remain current and accurate.
Proactively update records when new information or changes occur.
👥 Team Support & Training
Assist management in training and mentoring junior staff (Associates I and II) on:
Regulatory guidance and procedures
Internal processes
Use of databases and trackers
🚀 Process Improvement
Identify and contribute to process improvement initiatives to enhance regulatory efficiency, compliance, and data accuracy.
📌 Other Duties
Participate in special projects and perform additional responsibilities as assigned by management.
🎓 Education & Qualifications
Preferred Degree: M.Pharm in Regulatory Affairs (RA) or Quality Assurance (QA)
Alternative Qualifications: Equivalent advanced degree in a pharmaceutical discipline
💼 Experience
Minimum: 5+ years of experience in the pharmaceutical industry
Preferred Background: Regulatory Affairs, Analytical, Quality Assurance, Laboratory, or Production
🧠 Skills & Competencies
Strong understanding of ICH and FDA guidelines
Proven ability to evaluate regulatory documents and take appropriate action
Excellent verbal and written communication skills
Exceptional organizational, multitasking, and detail orientation
Strong critical thinking and logical reasoning abilities
Self-driven, proactive, and capable of working independently with minimal supervision
🧑🤝🧑 Internal Applicants
If you are currently employed at Teva, please apply via the Internal Career Site (Employee Central).
By applying internally, your application will receive priority consideration.
If you experience issues accessing your EC account, please contact your local HR or IT partner.
The internal portal is also accessible from your home network.
🌈 Equal Employment Opportunity (EEO) Commitment
Teva Pharmaceuticals is an Equal Opportunity Employer, committed to creating a diverse, inclusive, and accessible workplace.
Employment decisions are made without regard to:
Age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally protected status.
If you require accommodations during the recruitment and selection process, please notify us. All details will be handled confidentially to ensure a fair and supportive experience.
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