Job Title:
Regulatory Affairs Associate I – RA Publishing
Date Posted:
12 Sept 2025
Location:
Navi Mumbai, India, 400706
Company:
Teva Pharmaceuticals
Job ID:
64033
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 Regulatory Affairs Associate I – RA Publishing participates in publishing various regulatory activities, ensuring high-quality and timely submissions. This role serves as a primary interface with Regulatory Affairs Associates and supports EU, US, and Canadian submissions.
Key Responsibilities:
Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US, and Canada.
Handle post-approval submission publishing and transmit quality submissions to relevant regulatory agencies.
Perform document-level publishing activities, troubleshoot document issues, and conduct quality control checks for submission-ready documents according to agency guidance.
Collaborate with scientific personnel for planning, preparation, and publishing of documents.
Maintain working knowledge of internal and external publishing standards.
Apply basic knowledge of ICH and eCTD-related specifications and guidelines (eCTD, NeeS, paper) governing regulatory submissions.
Utilize technical systems such as Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, and Lorenz Validator.
Experience and Qualifications:
Education: B. Pharm, M. Pharm, or Master of Life Sciences.
Experience: 1–3 years, preferably with regulatory publishing experience in EU and US markets.
Strong command of spoken and written English.
Sensitivity to cultural diversity in a global organization.
Good understanding of regulatory IT systems.
Reporting:
Reports to: Manager – Regulatory Submission Management
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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