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Regulatory Affairs Associate I – EU Labeling & Translation Coordination-Apply by 20th August 2025

Teva Pharmaceuticals
Pharmacareer

Website Teva Pharmaceuticals

About Teva Pharmaceuticals 

Teva Pharmaceuticals is a global leader in generic and specialty medicines, dedicated to improving health and increasing access to quality healthcare solutions. With innovation, integrity, and excellence at our core, we empower professionals to make a meaningful difference worldwide.

Position Overview

Post: Regulatory Affairs Associate I
Job ID: 62841
Location: Bangalore, India
Department: Regulatory Affairs
Industry: Pharma / Healthcare / Clinical Research
Mode: Full-Time
Application Deadline: 20th August 2025

The Opportunity

As a Regulatory Affairs Associate I, you will play a pivotal role in supporting the EU Generics Labeling and Labeling Germany teams. Your responsibilities will span labeling, translation coordination, editorial review, and regulatory documentation in compliance with EU pharmaceutical regulations.

Key Responsibilities

Labeling & Documentation

  • Assist in providing accurate, regulatory-compliant product labeling for various EU regulatory procedures.

  • Review Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and packaging materials.

  • Ensure compliance with QRD templates and GRIDS database protocols.

Editorial Tasks

  • Perform proofreading and text editing.

  • Manage and update product-related content in regulatory systems.

  • Act as a GRIDS super-editor to maintain editorial consistency.

Translation Management for Centralized Procedures

  • Coordinate translation workflows for EU Centralized Procedures.

  • Liaise with local markets and translation agencies.

  • Oversee linguistic reviews and quality checks of translated materials.

Regulatory Monitoring

  • Stay abreast of EU regulatory changes through literature and guideline reviews.

  • Share updates relevant to central approvals and labeling standards.

Administrative Support

  • Release invoices and manage service contracts via SAP and ARIBA.

  • Coordinate cross-functional communication across internal and external teams.

Candidate Profile

  • Qualification: Diploma as a Pharmaceutical-Technical Assistant or Medical Assistant.

  • Experience in Regulatory Affairs or foundational knowledge of EU pharma law preferred.

  • Proficiency in MS Office and intermediate to advanced English skills.

  • Exposure to project management and cross-functional coordination is an advantage.

Why Teva?

  • Be part of a global healthcare leader with a presence in over 60 markets.

  • Work in a collaborative and diverse team culture.

  • Grow professionally through exposure to global regulatory frameworks and processes.

Apply by 20th August 2025 to be a part of Teva’s mission to make quality healthcare accessible to all.

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