Require Regulatory Affairs Associate at Teva | B.Pharm, M.Pharm
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. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.
Post : Regulatory Affairs Associate II
• Publish and dispatch major and complex routine/lifecycle management eCTD submission projects for US and Canada.
• Exposure in handling IND/NDA/ANDA 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 US submissions from pre-approval to post approval activities like Original application, Amendment, Supplement, Annual Report, PADER, 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)
• Notices when data appear wrong or incomplete, or needs verification. Distinguishes information that is not pertinent to a decision or solution.
• Assist with update of publishing process, SOPs and WIs.
• Collaborate with other publishers and perform the Quality Control Review of submission component documents.
• Must be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat, Lorenz Validator
• Compares observations or finished work to what is expected to find inconsistencies. Remains aware and takes care of details that are easy to overlook or dismiss as insignificant.
• Sees opportunities for creative problem solving while staying within the parameters of good practice. Generates unique but workable and useful solutions to difficult problems.
• Delivers products and services when and where the customer needs them. Explores options when unable to deliver a requested product or service, and pursues solutions until the customer is satisfied.
• 4-6 years in Regulatory Operations/Regulatory Affairs
Qualification : B. Pharm / M. Pharm / Master of Life Sciences
Location : Navi Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th September, 2019
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