Required Regulatory Affairs Associate at Teva - B.Pharm, M.Pharm or Masters in Life Sciences Apply

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

Job Description
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)
• Must be aware of Technical systems like Global Insight, Veeva Vault, ISI Toolbox, Adobe Acrobat, Lorenz Validator

Candidate Profile
• 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

Additional Information
Experience : 1–3 years
Qualification : B.Pharm, M.Pharm, or a Master's in Life Sciences
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May 2025