Job Title:
Regulatory Affairs Associate III
Location:
Bangalore, India, 560064
Date Posted:
September 8, 2025
Company:
Teva Pharmaceuticals
Job ID:
62828
Category:
Regulatory Affairs / Pharmaceutical Labeling
About Teva Pharmaceuticals:
Teva is a global pharmaceutical company focused on making health more affordable and accessible. With operations in nearly 60 countries, Teva manufactures generic, biosimilar, and innovative medicines, many of which are listed on the World Health Organization’s Essential Medicines List.
Job Overview:
The Regulatory Affairs Associate III ensures pharmaceutical, medical, and regulatory accuracy of product information (SmPC, labeling, PIL) for European procedures (MRP, DCP, CP) across innovative, biosimilar, and generic products. The role provides internal medical and regulatory expertise, ensures compliance with EU regulations, and coordinates with Pharmacovigilance and QA for safety updates.
Key Responsibilities:
1. Labeling:
Create and update compliant English product information for EU procedures.
Provide guidance to local RA teams (e.g., excipient-related calculations).
Collaborate with project teams on content for innovative products (pre- and post-approval).
Evaluate and approve change requests, coordinating submissions with EU regulatory units.
Collaborate on patent-related issues with the Global IP Group.
Contribute to PIL readability studies and ensure compliance with legal requirements.
Adapt product information to reference medicinal products (generic, hybrid, biosimilar).
Prepare Expert statements for type II variations and provide variation scope to RA.
Conduct plausibility checks and align wording with QRD requirements and module 3 standards.
2. Monitoring:
Monitor and communicate monthly safety updates from EU authority websites.
Track reference product updates and legal/regulatory changes affecting product information.
3. Pharmacovigilance Support:
Assess need for updates based on Company Core Safety Information (CCSI).
Implement PV-triggered and non-PV-triggered safety updates in compliance with SOPs.
Collaborate on safety-related actions with Pharmacovigilance and QA.
Participate in Product Safety Group (PSG) meetings.
Implement internal safety signals, including determining PIL wording.
4. Scientific Work & Authority Communication:
Respond to authority deficiency letters in collaboration with cross-functional teams.
5. Mockups:
Coordinate creation and approval of packaging mockups, Braille, and specimen designs.
Address authority queries and ensure compliance with EU regulations.
Qualifications & Experience:
Experience: 5–6 years in medicinal information, EU labeling, or Regulatory Affairs in the pharmaceutical industry.
Education: Completed 8-semester university degree in natural sciences (Pharmacy preferred, or Biology, Human Biology, Medicine, Food Chemistry).
Skills:
Advanced English (spoken and written)
Strong MS Office skills
Knowledge of European Pharmaceutical Law and Regulatory Affairs
Employment Type:
Full-time
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to equal employment opportunity and diversity. Employment decisions are made without regard to age, race, color, religion, sex, disability, pregnancy, sexual orientation, gender identity, veteran status, national or ethnic origin, or any other legally protected status.
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