Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.
Post : Regulatory Affairs Associate I
The opportunity
Regulatory Affairs associate I – RA publishing will participate in the publishing of different regulatory activities. The focus will be to ensure 100% quality and timeline of the submission. This role will be the primary interface with the Regulatory Affairs Associate.
Job Description
• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
• Exposure in handling post approval submissions publishing and transmitting quality submissions to agency.
• Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents as per the agency guidance.
• Collaborate with scientific personnel for planning, preparation and publishing
• Maintain working knowledge of internal and external publishing standards.
• Basic knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
• Must be aware of technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator
Candidate Profile
• B.Pharm / M.Pharm/ Master of Life Sciences.
• Total years of experience required for the role: 1-3 years (if any, preferred Regulatory Publishing experience in EU and US market)
• Command over spoken and written English
• Sensitivity to the cultural diversity of a global organization
• Good understanding of regulatory IT systems
Additional Information
Job Id : 66406
Experience : 1-3 years
Qualification : B.Pharm / M.Pharm / Master of Life Sciences
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th March 2026
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