Job Title: Regulatory Affairs Associate III
📅 Date Posted: October 1, 2025
📍 Location: Navi Mumbai, India – 400706
🏢 Company: Teva Pharmaceuticals
🆔 Job ID: 64203
🌍 About Teva Pharmaceuticals
At Teva Pharmaceuticals, we’re united by a 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 several products listed on the World Health Organization’s Essential Medicines List.
Every day, more than 200 million people take one of our medicines.
Operating in nearly 60 countries, we bring together diverse talents and nationalities, continuously striving for innovation, quality, and global health impact.
💡 The Opportunity
The Regulatory Affairs Associate III plays a pivotal role in preparing, reviewing, and submitting high-quality regulatory submissions to the U.S. FDA, ensuring compliance with all regulatory requirements and company timelines.
This role requires minimal supervision and involves independent evaluation of change controls (CCs), ensuring accuracy and completeness, and progressing them efficiently.
The incumbent will also maintain and update regulatory databases and trackers, manage Annual Reports, Supplements, and Post-Approval Submissions, while supporting team training and process improvements.
🧭 Key Responsibilities
📑 Regulatory Submissions
Prepare, review, and submit high-quality regulatory submissions to the FDA, adhering to company timelines and regulatory guidelines.
Maintain approved applications in full compliance with FDA regulations.
Independently request and compile documentation required for Annual Reports, finalize and publish for management review and dispatch.
Prepare and submit Supplements independently, incorporating feedback and proactively engaging with stakeholders for clarity on complex submissions.
🔄 Change Control Evaluation
Evaluate Change Controls (CCs) intended for post-approval changes.
Ensure CCs are accurate and complete, and progress them promptly in the absence of comments.
📊 Database & Tracker Management
Monitor all regulatory/team databases and trackers.
Proactively and accurately update records when changes occur to maintain up-to-date regulatory data.
🧠 Team Support & Training
Assist management in training and mentoring Associate I and Associate II team members on:
Regulatory guidance
Internal processes and procedures
Databases and tracking systems
🚀 Process Improvement
Identify and support process improvement initiatives to enhance regulatory efficiency and compliance.
📌 Other Responsibilities
Undertake additional projects and duties as assigned by management.
🎓 Education & Qualifications
Required:
Bachelor’s in Pharmacy
Preferred:
Master’s in Pharmacy, Science, or Life Sciences
💼 Experience
Minimum: 6+ years of Regulatory Affairs experience (preferably in US markets).
Demonstrated understanding of ICH and FDA guidelines.
Proven ability to evaluate regulatory documents and determine appropriate actions.
🧠 Skills & Competencies
Excellent verbal and written communication skills.
Strong organizational, analytical, and multitasking abilities.
High attention to detail and accuracy.
Proficient in critical and logical thinking.
Demonstrates initiative, accountability, and team collaboration.
🌈 Equal Employment Opportunity (EEO) Commitment
Teva Pharmaceuticals is an Equal Opportunity Employer.
We are dedicated to fostering a diverse, inclusive, and accessible workplace.
Employment opportunities are provided without discrimination based on:
Age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity/expression, ancestry, veteran status, national or ethnic origin, or any legally protected status.
If you require accommodations during the recruitment or selection process, please notify us. All information shared will remain confidential and used solely to ensure an inclusive candidate experience.
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