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Regulatory Affairs Associate I
Location: Bangalore, India – 560064
Company: Teva Pharmaceuticals
Job ID: 62840
About Teva Pharmaceuticals
Teva Pharmaceuticals is the world’s leading manufacturer of generic medicines, serving patients in nearly 60 countries. Every day, more than 200 million people rely on Teva products, many of which are listed on the World Health Organization’s Essential Medicines List. With a mission to make good health more affordable and accessible, Teva brings together diverse talent to innovate and deliver life-changing solutions.
The Opportunity
As a Regulatory Affairs Associate I, you will support EU Generics Labeling Managers and Labeling Germany Managers in ensuring pharmaceutically and medically accurate product labelling. You will play a key role in managing translations for EU Centralized Procedures (CPs) and coordinating with multiple stakeholders to ensure compliance with European pharmaceutical regulations.
Key Responsibilities
Editorial Tasks
- Review SmPC (Summary of Product Characteristics), PIL (Patient Information Leaflet), and packaging materials using review protocols.
- Adapt texts to the current QRD template and proofread documents.
- Ensure timely updates and provision of product information in the GRIDS regulatory database.
- Act as super-editor in GRIDS, coordinating queries from other departments and service providers.
Regulatory Environment Monitoring
- Track innovations in EU regulatory affairs, particularly in central approvals.
- Monitor relevant guidelines, literature, and best practices in the regulatory space.
Translation Management (EU CPs)
- Plan and execute translation processes for EU product information into member state languages (including Norway & Iceland).
- Coordinate with local markets, translation agencies, and conduct internal quality checks.
- Manage linguistic reviews and prepare submission-ready documents (annotated Word files, clean PDFs, translation tables).
Administrative & Financial Processes
- Act as Cost Center Administrator in SAP (invoice releases, accounting).
- Manage purchase requisitions via ARIBA for translation and service contracts.
Teamwork & Other Duties
- Collaborate in a team environment and adapt to evolving processes.
- Perform other related tasks as directed by management.
Qualifications & Skills
- Education: Completed training as a Pharmaceutical-Technical Assistant or Medical Assistant.
- Experience: Prior Regulatory Affairs experience or basic knowledge of European pharmaceutical law and the regulatory environment.
- Skills:
- Intermediate to advanced English proficiency (spoken & written).
- Excellent MS Office skills.
- Project management experience.
- Familiarity with European pharmaceutical regulations.
