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Regulatory Information Specialist

Introduction

Regulatory Information Specialist will support Regulatory Information Management by performing data entry into regulatory systems for planning, tracking and archiving purposes.

Function

  • Data entry into global regulatory systems (such as GPRS, Q&A database)
    • Data entry, archiving, tracking
  • Perform QC activities on the deliverables
  • Collaborate with PTR coordinators/product managers
  • Ensure overall submission quality
  • Assist in assuring adherence to current processes and standards and support development of new standards and processes
  • Assist technical teams to develop, validate and implement electronic processes and procedures

Requirements

  • A Bachelor Degree or equivalent in Life Sciences, or work experience in pharma or laboratory environment using similar high quality documentation standards
  • Excellent interpersonal and communication skills in English, orally & in written form
  • The candidate should be highly committed to quality even when working under pressure, should have sense of urgency
  • Excellent attention to details
  • Good computing skills – extensive experience in MS Word, Excel, Adobe Acrobat
  • Able to handle multiple project assignments, good time management
  • Flexibility to support changing assignments
  • Ability to work under minimal supervision
  • Ability to work with changing, sometimes high workload

Information

For more information, please contact Elena Berlingeri : e.berlingeri@tcs.com

Application

For more information, please contact Elena Berlingeri : e.berlingeri@tcs.com