Job Title
Regulatory Affairs Associate III
Job Details
Date Posted: August 20, 2025
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job ID: 63583
Who We Are
At Teva Pharmaceuticals, we’re on a mission to make good health more affordable and accessible for millions worldwide. With operations in nearly 60 countries and a diverse workforce, we are the world’s leading manufacturer of generic medicines and the producer of many WHO-listed Essential Medicines. Every day, 200+ million people globally take our medicines—and we’re always striving for new ways to make an impact.
The Opportunity
The Regulatory Affairs Associate III prepares, reviews, and submits high-quality regulatory submissions to the FDA, ensuring compliance with company timelines and regulatory guidelines. This role requires independent handling of change controls, submission processes, and database updates while contributing to the training and guidance of junior associates.
Key Responsibilities
Regulatory Submissions & Compliance
Prepare, review, and submit FDA regulatory submissions (Annual Reports, Supplements, Post-approval submissions).
Maintain approved applications in compliance with FDA regulations for assigned ANDA Annual Reports.
Independently request, compile, and finalize documentation for Annual Reports for management review and submission.
Change Control (CC) Management
Independently evaluate change controls for post-approval changes.
Ensure accuracy, completeness, and timely progression of CCs.
Complex Submissions
Compile and publish supplements for management review.
Proactively gather input from internal stakeholders to strengthen submissions.
Ensure accuracy and compliance for right-first-time submissions.
Mentoring & Training
Assist management in training Associate I and Associate II staff.
Provide guidance on regulatory processes, internal SOPs, trackers, and databases.
Process Improvement & Tracking
Monitor and update regulatory databases and trackers proactively.
Support process improvements and other assigned projects.
Experience & Qualifications
Education:
Bachelor’s in Pharmacy
Master’s in Pharmacy / Master’s in Science & Life Sciences preferred
Experience:
7–9 years in the pharmaceutical industry (Regulatory, Analytical, QA, Lab, or Production).
Minimum 6+ years in Regulatory Affairs (preferred).
Skills & Knowledge:
Strong understanding of ICH and FDA guidelines.
Ability to evaluate regulatory documents and determine appropriate actions.
Excellent verbal and written communication.
Strong organizational skills, attention to detail, and ability to multi-task.
Critical and logical thinking skills.
Travel
As required (not specifically mentioned).
Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to providing equal employment opportunities without discrimination based on age, race, color, religion, sex, disability, pregnancy, sexual orientation, gender identity/expression, veteran status, national origin, or any other legally protected status. We are dedicated to maintaining a diverse, inclusive, and accessible workplace.
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