Job Title:
Manager, Regulatory Affairs
Date Posted:
September 5, 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Company Overview:
Teva Pharmaceuticals is dedicated to making health more affordable and accessible, helping millions worldwide enjoy healthier lives. Operating in nearly 60 countries, Teva is a leading manufacturer of generic medicines and a producer of many WHO Essential Medicines.
Role Overview:
The Manager, Regulatory Affairs will manage regulatory submissions and compliance for Teva products in the APAC region (Australia, New Zealand, Singapore, Malaysia, etc.), supporting new product launches and maintaining regulatory standards for marketed products.
Key Responsibilities:
Regulatory Submissions & Compliance:
Manage all submissions and maintenance activities for Branded/Specialty and Generic products in APAC.
Ensure marketed products comply with local regulations by monitoring change controls with sites/suppliers and global RA work packages.
Manage post-approval changes, including variations, site transfers, and compliance-related activities to support supply continuity.
Maintain regulatory systems and databases (GRIDS, GI Insights, Teva Art, Veeva, etc.) in compliance with requirements.
Regulatory Guidance & Expertise:
Provide regulatory guidance to meet responsibilities as importer, distributor, and sponsor, ensuring safe and effective supply of medicines, including unapproved medicines where required.
Maintain up-to-date knowledge of APAC regulatory requirements and provide impact analyses to commercial teams.
Capture monthly RA activities via reports and maintain regulatory records for life cycle management and easy retrieval.
Monitor, collect, and interpret regulatory guidelines and trends to support strategy development and compliance.
Collaborate closely with market RA teams in the APAC region for all assigned activities.
Qualifications & Experience:
Education:
B. Pharm required; M. Pharm preferred
Experience:
Minimum 10 years in Regulatory Affairs
Strong knowledge of pharmaceutical and scientific processes, including registration and assessment of human medicinal products and medical devices
Experience with Generics, Biosimilars, or Innovative Medicines
Knowledge of regulatory and healthcare systems in APAC (Australia, New Zealand, Singapore, Malaysia preferred)
Application Notes:
Current Teva employees should apply via the internal career site (“Employee Central”) for priority consideration.
Teva Pharmaceuticals is committed to equal employment opportunities and a diverse, inclusive workplace. Accommodations during recruitment are treated confidentially.
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