Job Title:
Regulatory Affairs Associate I – RA Publishing
Date Posted:
September 12, 2025
Location:
Navi Mumbai, India, 400706
Company:
Teva Pharmaceuticals
Company Overview:
Teva Pharmaceuticals is committed to making health more affordable and accessible, helping millions globally live 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 Regulatory Affairs Associate I – RA Publishing participates in the publishing of regulatory submissions, ensuring 100% quality and adherence to submission timelines. This role serves as the primary interface with Regulatory Affairs Associates and contributes to efficient submission processes for multiple regions.
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 ensure high-quality submission delivery to regulatory agencies.
Perform document-level publishing activities, troubleshoot document issues, and conduct quality control checks to ensure submission readiness.
Collaborate with scientific personnel for planning, preparation, and publishing.
Maintain working knowledge of internal and external publishing standards.
Stay updated on ICH and eCTD specifications/guidelines for regulatory submissions (eCTD, NeeS, paper).
Operate and maintain proficiency in technical systems such as Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator.
Qualifications & Experience:
Education: B. Pharm, M. Pharm, or Master of Life Sciences.
Experience: 1–3 years of relevant experience; regulatory publishing experience in EU and US markets preferred.
Skills & Competencies:
Excellent command of spoken and written English.
Sensitivity to the cultural diversity of a global organization.
Understanding of regulatory IT systems.
Reporting Line:
Reports to Manager – Regulatory Submission Management
Equal Employment Opportunity:
Teva Pharmaceuticals is committed to equal opportunity employment and a diverse, inclusive workplace. All accommodations for recruitment and selection are treated confidentially.
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