Job Title:
Manager, Regulatory Affairs – APAC
Date Posted:
5 Sept 2025
Location:
Bangalore, India, 560064
Company:
Teva Pharmaceuticals
Job ID:
63860
Company Overview:
Teva Pharmaceuticals is a global leader in generic medicines and a producer of many products on the WHO Essential Medicines List. Teva’s mission is to make healthcare more affordable and accessible, positively impacting millions of people worldwide. Operating in nearly 60 countries, Teva values diversity, inclusion, and innovation in advancing global health.
Role Overview:
The Manager, Regulatory Affairs (APAC), is responsible for managing the submission and approval process for Teva products in the APAC region (Australia, New Zealand, Singapore, Malaysia, etc.) and ensuring regulatory compliance. The role supports business opportunities, product launches, and maintains regulatory intelligence for effective decision-making across the region.
Key Responsibilities:
Regulatory Submissions:
Manage all submissions and maintenance activities for Branded, Specialty, and Generic products in the APAC region.
Ensure full compliance of marketed products with local regulations.
Proactively manage and monitor change controls with sites, suppliers, and global RA workplans.
Handle local regulatory planning for post-approval changes, including variations, site transfers, and compliance activities.
Maintain and update regulatory systems (GRIDS, GI Insights, Teva Art, Veeva, etc.) to ensure compliance.
Regulatory Intelligence / Expertise / Guidance:
Provide regulatory guidance to ensure Teva meets obligations as an importer, distributor, and sponsor.
Maintain up-to-date knowledge of regulatory requirements and trends in APAC.
Capture and report monthly RA activities in regulatory tracking systems.
Maintain regulatory records and files electronically for lifecycle management in accordance with global and local standards.
Analyze regulatory guidelines and trends, communicate impacts to commercial teams, and assist in developing strategies and action plans.
Collaborate with market RA teams across APAC to complete assigned activities.
Product Launch Support:
Support new product launches by coordinating regulatory requirements.
Provide technical input for artwork approval and product-related materials required for market introduction.
Experience and Qualifications:
Education: B. Pharm / M. Pharm (preferred).
Experience: 10+ years in Regulatory Affairs.
Strong knowledge of pharmaceutical and scientific processes, including registration and assessment of human medicinal products and medical devices.
Experience in Generics, Biosimilars, or Innovative Medicines in Regulatory Affairs, preferably in APAC.
Knowledge of regulatory and healthcare systems in APAC countries (Australia, New Zealand, Singapore, Malaysia).
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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