Teva is a global pharmaceutical leader and the worlds largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day.
Post : Regulatory Affairs Associate I - Submission Publishing
• 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
• Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems
• B.Pharm/ M.Pharm/ Master of Life Sciences – M Pharm preferred
• Total years of experience required for the role: 2-4 years (preferred - Regulatory Publishing experience in EU and US market)
• Command over spoken and written English
• Sensitivity to the cultural diversity of a global organization
Qualification : B.Pharm/M.Pharm/ Master of Life Sciences
Location : Navi Mumbai, Maharashtra
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 20th April, 2022
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