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. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.
Post : Regulatory Affairs Associate II - 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 for self as well as peers.
• Hands on expertise in EU 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.
• Act as backup and support to group leader in his/her responsibilities
• Taking responsibility and initiative in upcoming projects and forecast the challenges
• Plan the trainings/knowledge sharing sessions which helps team to develop their skills
Candidate Profile :
• B.Pharm / M.Pharm / Master of Life Sciences – M.Pharm preferred
• 4-6 years (preferred - Regulatory Publishing experience in EU and US market)
Qualification : B.Pharm/M.Pharm/ Master of Life Sciences/M.Pharm
Location : Navi Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May, 2021
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