Mgr Ra Eu Generics Labeling

10+ years

Not Disclosed

Bangalore

10 Sept. 22, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Manager – Regulatory Affairs (EU Generics Labeling)

Date Posted:

14 Sept 2025

Location:

Bangalore, India, 560064

Company:

Teva Pharmaceuticals

Job ID:

62827

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 Manager – RA EU Generics Labeling ensures 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. This role provides internal pharmaceutical and medical expertise, resolves labeling issues, ensures regulatory compliance, and leads strategic planning and implementation of labeling updates.

Key Responsibilities:

Labeling:

Create and update compliant English product information for EU procedures.
Strategically plan and implement changes affecting multiple product information documents.
Determine implementation plans and track updates due to new requirements (e.g., excipient warnings, QRD template updates).
Provide instructions and guidance to local RA teams.
Discuss content of product information for innovative products in project teams (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; ensure PIL readability and compliance.
Adapt information to reference medicinal products (generic, hybrid, biosimilar).
Prepare Expert Statements for type II variations and provide variation scope to RA teams.
Perform plausibility checks and ensure wording aligns with QRD requirements and Standard Terms for module 3 updates.

Monitoring:

Monthly monitoring and communication of safety updates from EU authority websites.
Track reference product updates and changes in legal/guidance affecting product information.

Pharmacovigilance (PV):

Assess 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 on safety-related actions with PV and QA teams.
Participate in Product Safety Group (PSG) meetings.
Implement internal safety signals, including PIL wording updates.

Scientific Work & Authority Communication:

Participate in project teams to define regulatory strategy and prepare expert statements.
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.

Training:

Assist in training new team members.

Experience and Qualifications:

Experience: 10+ years of total experience; minimum 6–7 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), preferably with a PhD.
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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