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Friday, October 25, 2019

Teva pharmaceuticals hiring for Associate - Regulatory Affairs | Apply Now

Teva pharmaceuticals hiring for Associate - Regulatory Affairs | Apply Now
Hiring for Regulatory Affairs Associate I - Publishing
Department: Regulatory Affairs
Position: Associate I - Publishing
Qualification: B.Pharm / M.Pharm / Master of Life Sciences
Experience: 2 - 4 Years relevant experience in Regulatory Operations / Regulatory Affairs (Regulatory Publishing experience in EU and US market will be preferred)
Work Location: Navi Mumbai
Job 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 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.

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