The GSC Submission Management department was established in 2010, with the purpose of delivering high-quality registration dossiers to our affiliates worldwide. The focus area of our department is to provide a superior service to our stakeholders consistently and add value to our submission processes in terms of standardization and efficiency.

Position: Associate Analyst РRegulatory Operations

  • Compilation and delivery of country-specific¬†files across IO for Renewals and Additional Manufacturing sites by preparing an operational plan and checklist of local requirements for each submission.
  • Circulate the plans and requirements to RA in Affiliate for confirmation, TOC compilation according to compliance form or according to Site Transfer TOCs provided by RA CMC & Devices: search for documents in novoDOCS and populate TOC, Raise Publishing Online Form request according to submission size and publishing lead-times and QC of Published Output and Maintain the submission tracker.

Qualifications

The knowledge, skills, and experience will be required.

  • Graduate or Post Graduate in Science or comparable degree in a computer-related field or equivalent professional experience
  • Around 5 years of experience in the Pharmaceutical Industry in Regulatory Affairs
  • Experience in compilation of Registration/Re-registration dossier in National/eCTD/NeeS and Standard format
  • Experience in Document Management system
  • Speaks and writes English at a professional level
  • Is service minded and customer-oriented
  • Demonstrates a high-quality mindset
  • Structured and organized and able to maintain the overview
  • Ability to work in teams
  • Ability to perform in peak periods, work under tight deadlines and under a high workload
  • Focuses on targets and delivers results
  • Act proactively
  • Works independently
  • Good Analytical Skills
  • Easily adaptable to the team environment
  • Strong work ethics and integrity

Last Date for Application: 15th June 2020

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