Job Title: Regulatory Affairs Associate I
Location: Navi Mumbai, India (400706)
Company: Teva Pharmaceuticals
Job Type: Full-Time
Experience Required: 2+ years
Job ID: 65574
Functional Area: Regulatory Affairs / Pharmaceutical
Company Overview
Teva Pharmaceuticals is a global leader in generic medicines, committed to making healthcare more affordable and accessible. Operating across nearly 60 countries, Teva produces many medicines on the World Health Organization’s Essential Medicines List, helping over 200 million people worldwide every day. Joining Teva means contributing to a mission-driven company that values diversity, innovation, and patient-centric solutions.
Role Overview
We are seeking a Regulatory Affairs Associate I to support FDA submissions, annual report preparations, and regulatory compliance for pharmaceutical products. Reporting to the Manager or designee, the Associate will assist with supplements, amendments, change control reviews, and database maintenance, ensuring accuracy and adherence to regulatory guidelines.
This role provides hands-on experience in regulatory documentation and compliance within a collaborative team environment, ideal for professionals aiming to advance their career in Regulatory Affairs.
Key Responsibilities
Prepare annual reports, and assist with supplements and amendments for FDA submissions under direct supervision.
Review supporting documents for change controls, including batch records, methods, and specifications, to ensure compliance and quality.
Familiarize with applicable FDA regulations and guidance to support filing determinations and regulatory processes.
Accurately maintain regulatory databases, trackers, and approved applications in real time.
Support additional regulatory projects and duties as assigned.
Qualifications & Experience
Education: M. Pharm (RA/QA discipline preferred) or equivalent life sciences degree.
Experience: Minimum 2 years in Regulatory Affairs or related roles (analytical/QC, R&D, laboratory, or production) within pharmaceutical or biotech industries.
Technical Skills: Proficiency in Microsoft Word, Excel, and internet-based tools.
Strong organizational, multi-tasking, and prioritization skills.
Excellent verbal and written communication abilities.
Ability to work independently and collaboratively in a team environment.
Attention to detail and commitment to quality and compliance.
Why Join Teva
Contribute to the development and compliance of medicines that impact millions globally.
Gain hands-on experience in regulatory submissions, FDA compliance, and documentation processes.
Work in a diverse and inclusive environment that values professional growth and innovation.
Be part of a global pharmaceutical leader committed to improving patient outcomes.
Equal Opportunity Employer
Teva Pharmaceuticals is committed to providing equal employment opportunities without regard to age, race, color, religion, sex, disability, gender identity, sexual orientation, veteran status, or any other legally protected status. Accommodation requests during recruitment will be handled confidentially.
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