Job Title:
Regulatory Affairs Associate III – EU Labeling
Date Posted:
8 Sept 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Job ID:
62828
Company Overview:
Teva Pharmaceuticals is a global leader in generic, innovative, and biosimilar medicines, committed to making healthcare more affordable and accessible. Teva operates across nearly 60 countries and is a trusted producer of many products on the WHO Essential Medicines List.
Role Overview:
The Regulatory Affairs Associate III ensures the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, Labeling, PIL) for EU procedures (MRP, DCP, CP) for innovative, biosimilar, and generic products. The role provides internal pharmaceutical and medical expertise, addresses regulatory inquiries, resolves labeling issues, and ensures compliance with EU regulations.
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 excipients or warnings).
Discuss product information content for innovative products in project teams (pre- and post-approval).
Evaluate and approve change requests; coordinate submissions with EU regulatory units.
Collaborate with the Global IP Group on patent-related issues.
Contribute to readability studies and ensure PIL compliance with legal requirements.
Adapt product information to reference medicinal products (generic, hybrid, biosimilar).
Prepare Expert Statements (justifications) for type II variations.
Conduct plausibility checks and ensure wording aligns with QRD requirements and Standard Terms for module 3 updates.
Monitoring:
Perform monthly monitoring and communicate safety updates from EU authority websites.
Track reference product updates and legal/guidance changes affecting product information.
Pharmacovigilance (PV):
Assess the need for updates based on Company Core Safety Information (CCSI).
Implement PV-triggered and non-PV-triggered safety updates (e.g., PRAC/PSUSA/PSUFU, Referrals, Article 30 procedures) in line with SOPs.
Collaborate with Pharmacovigilance and QA on safety-related actions.
Participate in Product Safety Group (PSG) meetings.
Implement internal signals, including determining PIL wording.
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 compliance with EU regulations.
Experience and Qualifications:
Experience: 5–6 years in medicinal information and EU labeling within Regulatory Affairs.
Education: Completed at least an 8-semester university degree in natural sciences (e.g., Pharmacy [preferred], Biology, Human Biology, Medicine, Food Chemistry).
Skills: Advanced English (spoken and written), strong MS Office skills, knowledge of European Pharmaceutical Law and Regulatory Affairs.
Internal Applicants:
Current Teva employees should apply via the internal career site on “Employee Central” for priority consideration and access to internal-only opportunities.
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to equal employment opportunity. Employment decisions are based on merit, qualifications, and business requirements without regard to age, race, creed, color, religion, sex, disability, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations are provided to support candidates during the recruitment process.
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