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. 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.
Teva Pharmaceuticals, hiring Freshers & experience B.Pharm/ M.Pharm/ Master of Life Sciences candidates for Regulatory Affairs Associate I
Job Description
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.
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
Qualifications: B.Pharm/M.Pharm/ Master of Life Sciences – M.Pharm preferred
Experience Total years of experience required for the role: 2-4 years (preferred – Regulatory Publishing experience in EU and US market)
Freshers can also be considered
Function
Regulatory Affairs
Sub Function
Medical Regulatory Affairs
