Tevapharm

Regulatory Affairs Associate I - Publishing (BB-73792)

Found in: Talent IN

Description:

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
  • Function

    Regulatory Affairs

    Sub Function

    Medical Regulatory Affairs

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    calendar_today2 days ago

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    location_on Navi Mumbai, India

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