Teva Pharmaceuticals Ltd Job Opening for Regulatory Affairs
Regulatory Affairs-Submission Publishing role with Teva Pharmaceuticals
Job Location: Navi Mumbai
Years of experience: 2-4
Roles & Responsibilities:
-Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for EU, US and Canada.
-Exposure in handling initial 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, publishing and quality control checks of submissions.
-Hands on expertise in EU and US submissions from pre-approval to post approval activities like initial, variations, PSUR etc.
-Participate in Global Regulatory Affairs project teams
-Maintain working knowledge of internal and external publishing standards.
-Knowledge of ICH and eCTD related specification/guidelines governing regulatory submissions (eCTD, NeeS, paper)
-Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
If your profile matches the above requirement, please share your updated resume to pranita.padte@teva.co.in with subject line as “Regulatory Affairs – Publishing”
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