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JUNIOR REGULATORY METADATA COORDINATOR (NT)

Hungary - Budapest

Tech People is a European provider of technical skills permanent recruitment and temporary contracting services for multiple industries.

Currently we are looking for

JUNIOR REGULATORY METADATA COORDINATOR (NT)


Location: Budapest, XI., hybrid (2 days in office)

Salary: competitive

Type of employment: employee

Start: ASAP


Responsibilities:

  • Assist the Publishing and Regulatory Data Entry Manager with global submission views and strategy according to Regulatory Strategic Planning
  • Assist in the planning of regulatory submissions
  • Make sure all data received from and submitted to the Health Authorities is accurate and that the tracking system is aligned
  • Review the impact of the submission strategy on the Regulatory Tracking System and ensure it is maintained appropriately
  • Control the quality of internal data entry
  • Assist RA communities in tracking regulatory information through training, coaching, and mentoring
  • Ensure that all stakeholders have access to accurate and up-to-date regulatory information about products under development, approved and marketed worldwide

Requirements:

  • Ideally, you should have a bachelor's degree in life sciences or pharmacy
  • Regulatory affairs and submissions experience of two years
  • An understanding of standard software packages, and Regulatory Information Management (RIM) and regulatory tracking systems is preferred
  • International regulatory experience in the EU and US
  • Experience in a centralized data entry organization
  • Excellent written and verbal communication skills in English.
  • Candidate needs to be currently eligible to work in Hungary


To apply for this opportunity, please register you CV, or for more information +36 30 364 6154 Nikolett Rózsás

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