Teva Regulatory Affairs Associate 

India, Maharashtra, Navi Mumbai 

957087440

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

• 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)
• Mustbe aware of Technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

• B. Pharm, M. Pharm, or a Master's in Life Sciences
• Experience required:1–3 years of experience required for the role (preferably with regulatory publishing experience in the EU and US markets).
• Strong command of spoken and written English
• Sensitivity to the cultural diversity of a global organization.
• Good understanding of regulatory IT systems

Manager – Regulatory Submission Management