Manager – Regulatory Affairs EU Generics Labeling
Location: Bangalore, India (560064)
Employment Type: Full-Time
Function: Regulatory Affairs | EU Labeling | Generics & Biosimilars
Industry: Pharmaceuticals | Life Sciences
Job ID: 62830
Company: Teva Pharmaceuticals
Date Posted: January 29, 2026
About the Company
Teva Pharmaceuticals is a global leader in innovative biopharmaceuticals and high-quality generics, with a strong presence across Europe and worldwide. Teva is committed to improving patient health by delivering accessible medicines while fostering a collaborative, inclusive, and growth-oriented workplace.
Role Overview
The Manager – Regulatory Affairs EU Generics Labeling is responsible for ensuring the pharmaceutical, medical, and regulatory accuracy of English-language product information for European regulatory procedures, including MRP, DCP, and Centralised Procedures (CP). This role supports generic, biosimilar, hybrid, and innovative products and serves as a subject matter expert for EU labeling compliance, authority interactions, and cross-functional coordination.
The position plays a critical role in maintaining regulatory compliance, managing safety-driven updates, and supporting strategic labeling activities across the EU product portfolio.
Key Responsibilities
EU Labeling Strategy & Compliance
Develop, review, and maintain EU-compliant English product information, including SmPC, Package Leaflet (PIL), and labeling.
Ensure alignment with QRD templates, EU Standard Terms, and evolving regulatory requirements.
Plan and implement labeling changes impacting multiple products, including excipient warnings, safety updates, and legal or guideline-driven changes.
Adapt labeling to reference medicinal products for generic, hybrid, and biosimilar applications.
Perform plausibility checks and ensure regulatory accuracy for Module 3 updates and variations.
Regulatory Operations & Submissions
Evaluate and approve labeling change requests and coordinate submissions with EU Regulatory Affairs teams.
Define the scope of variations and prepare expert statements and justifications, including for Type II variations.
Support responses to health authority deficiency letters in collaboration with internal stakeholders.
Collaborate with the Global IP team on patent-related labeling considerations.
Pharmacovigilance & Safety Labeling
Assess the need for labeling updates based on Company Core Safety Information (CCSI).
Implement PV-triggered and non-PV-triggered safety updates, including PRAC, PSUSA, PSUFU, referrals (Articles 30, 31, 107i), in accordance with SOPs.
Participate in Product Safety Group (PSG) meetings and implement internal safety signals, including PIL wording.
Monitoring & Intelligence
Conduct monthly monitoring of EU authority communications and safety updates.
Track reference product changes, regulatory guidance updates, and legal developments impacting EU labeling.
Mockups & Packaging Compliance
Coordinate creation, review, and approval of packaging mockups, Braille text, and specimens.
Address authority queries and ensure full compliance with EU packaging and labeling regulations.
Cross-Functional Collaboration & Training
Provide pharmaceutical and medical expertise to internal teams and respond to authority-related inquiries.
Participate in cross-functional project teams to define regulatory strategies for pre- and post-approval products.
Support readability studies and ensure PIL compliance with legal requirements.
Assist in onboarding and training new team members.
Experience & Qualifications
Education
Minimum 8-semester university degree in Natural Sciences such as Pharmacy (preferred), Biology, Human Biology, Medicine, or Food Chemistry.
PhD is highly desirable.
Experience
10+ years of total professional experience in the pharmaceutical industry.
Minimum 6–7 years of hands-on experience in EU medicinal product information and labeling, ideally within Regulatory Affairs.
Strong experience supporting EU generics, biosimilars, and innovative products across MRP, DCP, and CP procedures.
Skills & Knowledge
Advanced proficiency in written and spoken English.
In-depth knowledge of European pharmaceutical law, EU regulatory frameworks, and labeling requirements.
Strong understanding of pharmacovigilance-driven labeling updates.
Excellent organizational, stakeholder management, and cross-functional communication skills.
Advanced proficiency in MS Office applications.
Why Join Teva
Teva offers a supportive and flexible work environment focused on professional growth, employee wellbeing, and meaningful contributions to global healthcare. Employees benefit from structured career development, internal mobility opportunities, and access to learning platforms that support continuous advancement.
Reporting Line
Reporting Manager: In process of validation
This opportunity is ideal for senior regulatory professionals seeking to lead EU generics labeling strategy within a global pharmaceutical organization.
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