Job Title:
Regulatory Affairs Associate III – EU Labeling
Date Posted:
September 8, 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Company Overview:
Teva Pharmaceuticals is committed to making health more affordable and accessible, helping millions globally live healthier lives. Operating in nearly 60 countries, Teva is a leading manufacturer of generic medicines and a producer of many WHO Essential Medicines.
Role Overview:
The Regulatory Affairs Associate III ensures the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for European procedures (MRP, DCP, CP) for innovative, biosimilar, and generic products. The role provides internal pharmaceutical and medical expertise to resolve labeling issues and ensures regulatory compliance.
Key Responsibilities:
Labeling:
Create and update compliant English product information for EU procedures.
Provide instructions and guidance to local RA teams (e.g., calculations for new excipient warnings).
Discuss product information content for innovative products (pre- and post-approval) in project teams.
Evaluate and approve change requests; coordinate submissions with EU regulatory units.
Collaborate on patent-related issues with Global IP Group.
Contribute to readability studies and ensure PIL readability and legal compliance.
Adapt product information to reference medicinal products (generic, hybrid, biosimilar procedures).
Prepare Expert Statements (justifications) for Type II variations.
Perform plausibility checks and ensure wording aligns with QRD requirements and Standard Terms for module 3 updates.
Monitoring:
Track monthly updates from EU authority websites and communicate safety updates.
Monitor reference product updates and legal/regulatory changes affecting product information.
Pharmacovigilance:
Assess updates required based on Company Core Safety Information (CCSI).
Implement PV-triggered and non-PV-triggered safety updates in line with SOPs.
Collaborate with Pharmacovigilance and QA on safety-related actions.
Participate in Product Safety Group (PSG) meetings.
Implement internal signals, including PIL wording adjustments.
Scientific Work & Authority Communication:
Respond to authority deficiency letters in collaboration with other departments.
Mockups:
Coordinate creation and approval of packaging mockups, Braille, and specimens.
Address authority queries and ensure EU regulatory compliance.
Qualifications & Experience:
Education: Minimum 8-semester university degree in natural sciences (Pharmacy preferred, Biology, Human Biology, Medicine, Food Chemistry).
Experience: 5–6 years in medicinal information and EU labeling, preferably in Regulatory Affairs.
Skills:
Advanced English (spoken and written).
Strong MS Office skills.
Knowledge of European pharmaceutical law and regulatory affairs.
Application Notes:
Current Teva employees should apply through Employee Central for priority consideration.
Equal Employment Opportunity:
Teva Pharmaceuticals is committed to equal opportunity employment and a diverse, inclusive workplace. Accommodations during recruitment are treated confidentially.
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