Job Title:
Regulatory Affairs Associate III
Date Posted:
20 Sept 2025
Location:
Navi Mumbai, India, 400706
Company:
Teva Pharmaceuticals
Job ID:
63515
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. With operations in nearly 60 countries, Teva values diversity, inclusion, and innovation in advancing global health.
Role Overview:
The Regulatory Affairs Associate III is responsible for managing regulatory applications through the approval process, including post-approval submissions to Health Canada (HC). The role works independently, provides professional regulatory guidance, and keeps management informed of significant regulatory issues affecting assigned products and projects.
Key Responsibilities:
Prepare, compile, review, and submit high-quality post-approval submissions in compliance with Health Canada regulations and corporate standards.
Develop and implement regulatory strategies for assigned projects until approval and product launch.
Interface with R&D and other business functions to ensure timely execution of project-specific regulatory strategies.
Evaluate change controls for regulatory filing assessments in accordance with HC guidance documents.
Ensure timely completion of all post-approval regulatory activities as applicable.
Stay current with Teva work procedures, Health Canada regulations and guidance, and ICH regulations.
Perform business development assessments, as applicable.
Handle other projects and duties as assigned.
Required Qualifications:
M. Pharma degree in a scientific discipline.
Minimum 5–7 years of experience in regulatory affairs focusing on post-approval activities (EU/FDA, with preference for HC).
Overall pharmaceutical industry experience: 7–10 years.
Strong oral and written communication skills.
Excellent organizational skills, ability to multi-task, and attention to detail.
Strong critical and logical thinking skills.
Preferred Qualifications:
Experience with sterile products.
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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