Job Title:
Manager, Regulatory Affairs – EU Generics Labeling
Location:
Bangalore, India – 560064
Company:
Teva Pharmaceuticals
Job ID:
62827
Posting Date:
September 14, 2025
Company Overview:
Teva Pharmaceuticals is a global leader in generic medicines and a producer of many products on the World Health Organization’s Essential Medicines List. Teva’s mission is to make health care more affordable and accessible, impacting millions of lives worldwide.
Role Summary:
The Manager, RA EU Generics Labeling is responsible for ensuring the pharmaceutical, medical, and regulatory accuracy of English product information (SmPC, labeling, PIL) for EU procedures (MRP, DCP, CP) of innovative, biosimilar, and generic products. The role provides expertise in labeling compliance, responds to regulatory inquiries, and implements changes in alignment with European regulations.
Key Responsibilities:
Labeling:
Create and update compliant English product information for EU procedures.
Strategically plan and implement updates affecting multiple product information documents.
Determine and track implementation plans for updates (e.g., excipient warnings, QRD template changes).
Provide guidance to local RA teams regarding regulatory requirements.
Review product information content for innovative products (pre- and post-approval).
Evaluate and approve change requests; coordinate submissions with EU regulatory units.
Collaborate with Global IP Group on patent-related issues.
Contribute to readability studies ensuring PIL compliance with legal requirements.
Adapt product labeling to reference medicinal products for generic, hybrid, or biosimilar procedures.
Prepare expert statements/justifications for type II variations.
Perform plausibility checks and ensure wording aligns with QRD requirements.
Monitoring:
Monitor EU authority websites for safety updates.
Track reference product updates and legal/regulatory guidance affecting product information.
Pharmacovigilance:
Assess need for labeling 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).
Participate in Product Safety Group (PSG) meetings.
Determine PIL wording based on internal signals and safety data.
Scientific Work & Authority Communication:
Participate in project teams for regulatory strategy development.
Prepare expert statements for regulatory submissions.
Respond to authority deficiency letters in collaboration with cross-functional teams.
Mockups & Packaging:
Coordinate creation and approval of packaging mockups, Braille, and specimens.
Address authority queries to ensure compliance with EU regulations.
Training & Team Support:
Assist in onboarding and training new team members.
Qualifications & Experience:
Experience:
Minimum 10+ years of total experience, with 6–7 years in medicinal information and EU labeling within the pharmaceutical industry.
Strong experience in Regulatory Affairs and EU labeling compliance.
Education:
University degree (minimum 8 semesters) in natural sciences (Pharmacy preferred, Biology, Human Biology, Medicine, Food Chemistry).
PhD preferred.
Skills & Competencies:
Advanced English (spoken and written).
Strong MS Office skills.
In-depth knowledge of European pharmaceutical law and regulatory affairs.
Ability to manage multiple projects, prioritize work, and communicate effectively.
Equal Opportunity Statement:
Teva Pharmaceuticals is committed to equal employment opportunity and fostering a diverse and inclusive workplace. Accommodations are provided for candidates throughout the recruitment process as needed.
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