Teva Pharmaceuticals is a global leader in generic and specialty medicines, committed to making healthcare more affordable and accessible. With a presence in nearly 60 countries, Teva produces many medicines on the WHO Essential Medicines List, impacting over 200 million lives daily. The company fosters a diverse, inclusive workplace, driving innovation in the pharmaceutical industry.
Detailed Job Description
Job Title: Regulatory Affairs Associate I
Location: Bangalore, India
Job ID: 62841
Key Responsibilities:
Editorial Tasks
- Review SmPC, PIL, and packaging materials using review protocols.
- Adapt texts to QRD templates and ensure accuracy.
- Proofread regulatory documents and update GRIDS database.
- Act as a super-editor (GRIDS) and coordinate with internal teams.
Translation Management (EU Centralized Procedures – CPs)
- Plan and coordinate translations of product information into EU languages.
- Liaise with translation agencies & local markets for linguistic reviews.
- Conduct QC checks and prepare submission documents (annotated Word, clean PDFs).
Regulatory & Administrative Tasks
- Monitor EU regulatory updates (guidelines, best practices).
- Handle SAP cost center administration (invoices, accounting).
- Manage purchase requisitions (ARIBA) for translation services.
Work Environment
- Collaborate in a global team supporting EU regulatory processes.
- Opportunity to work on high-impact generic medicines.
Eligibility & Qualifications
- Education: Training as a pharmaceutical-technical assistant or medical assistant.
- Experience: Basic knowledge of EU pharmaceutical law & regulatory affairs.
- Skills:
- Intermediate/Advanced English (written & spoken).
- Strong MS Office proficiency.
- Project management experience is a plus.
Benefits at Teva Pharmaceuticals
✅ Competitive salary & growth opportunities
✅ Inclusive & diverse workplace
✅ Exposure to global regulatory processes
✅ Work with life-saving generic medicines