Manager – Regulatory Affairs (EU Generics Labeling)
Date Posted: December 31, 2025
Job ID: 62830
Company: Teva Pharmaceuticals
Location: Bangalore, India (560064)
Employment Type: Full-time
Industry: Pharmaceuticals | Regulatory Affairs | EU Labeling
About Teva Pharmaceuticals
Teva Pharmaceuticals is a global leader in generic medicines, committed to making high-quality healthcare more affordable and accessible worldwide. With operations across nearly 60 countries, Teva’s diverse workforce supports millions of patients who rely on Teva medicines every day, including many listed on the World Health Organization’s Essential Medicines List.
Job Overview
Teva Pharmaceuticals is seeking an experienced Manager – Regulatory Affairs (EU Generics Labeling) to ensure the pharmaceutical, medical, and regulatory accuracy of English product information for European regulatory procedures. This role supports innovative, biosimilar, and generic products under MRP, DCP, and Centralized Procedures (CP) and plays a critical role in maintaining compliance with evolving EU regulatory and safety requirements.
The ideal candidate will bring deep expertise in EU labeling regulations, medicinal product information, pharmacovigilance-driven updates, and authority interactions.
Key Responsibilities
EU Labeling & Regulatory Compliance
Create, review, and maintain compliant English product information including SmPC, Package Leaflet (PIL), and labeling for EU procedures (MRP, DCP, CP)
Strategically plan and implement labeling changes impacting multiple product information documents
Define and track implementation plans for new regulatory requirements (e.g., excipient warnings, QRD template updates)
Provide guidance and instructions to local Regulatory Affairs teams on labeling implementation activities
Evaluate and approve labeling change requests and coordinate submissions with EU regulatory units
Scientific & Cross-Functional Collaboration
Participate in project teams for pre- and post-approval labeling discussions of innovative, biosimilar, and generic products
Collaborate with the Global IP team on patent-related labeling matters
Prepare expert statements and justifications for Type II variations and define the regulatory scope of variations
Perform plausibility checks and ensure wording alignment with QRD templates, Standard Terms, and EU guidance
Safety, Pharmacovigilance & Monitoring
Assess labeling updates based on Company Core Safety Information (CCSI)
Implement PV- and non-PV-triggered safety updates including PRAC, PSUSA, PSUFU, referrals (Articles 31 & 107i), and Article 30 procedures
Collaborate closely with Pharmacovigilance and Quality teams to ensure timely safety-related updates
Participate in Product Safety Group (PSG) meetings
Monitor EU authority websites for monthly safety communications, reference product updates, and regulatory guidance changes
Authority Communication & Mockups
Respond to health authority deficiency letters in coordination with cross-functional teams
Coordinate the creation and approval of packaging mockups, Braille text, and specimen materials
Address authority queries related to labeling and packaging compliance
Training & Knowledge Sharing
Support onboarding and training of new team members on EU labeling requirements and internal processes
Educational Qualifications
Minimum 8-semester university degree in Natural Sciences such as Pharmacy (preferred), Biology, Human Biology, Medicine, or Food Chemistry
PhD in a relevant discipline is preferred
Experience Required
10+ years of total professional experience
6 to 7 years of hands-on experience in EU medicinal product information and labeling, preferably within Regulatory Affairs
Proven experience working with EU regulatory procedures (MRP, DCP, CP)
Key Skills & Competencies
In-depth knowledge of European pharmaceutical legislation and EU regulatory frameworks
Strong expertise in SmPC, PIL, labeling lifecycle management, and QRD compliance
Excellent written and spoken English communication skills
Strong proficiency in MS Office and regulatory documentation tools
Ability to work independently and collaborate across global, cross-functional teams
High attention to detail and strong analytical skills
Equal Employment Opportunity
Teva Pharmaceuticals is an Equal Employment Opportunity Employer and is committed to fostering a diverse and inclusive workplace. Employment decisions are made without regard to age, race, color, religion, sex, disability, pregnancy, sexual orientation, gender identity or expression, national origin, veteran status, or any other legally protected status.
Teva also provides reasonable accommodations throughout the recruitment process to ensure an accessible candidate experience.
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