Regulatory Affairs Specialist

RAS Hungary

Join our global team as a Regulatory Affairs Specialist.

Regulatory Affairs Specialist is responsible for assigned projects and related tasks, applications and dossiers submissions, communication with clients and national authorities.

Position is in Hungary.

 

Responsibilities:

  • Manage Medicinal Products and Medical Devices regulatory affairs related activities for Hungary and other countries
  • Coordinate with experts in various countries
  • Compile, coordinate and monitor applications for registration, notifications, renewals, variations/changes for medicinal products and medical devices in accordance with the national and EU legislation and standard operating procedures
  • Make regulatory monitoring of the current duties related with particular product in the territory
  • Maintain contact with testing/technical companies, regulatory authorities, client/sponsor representative
  • Provide the Regulatory team with regulatory input in order to obtain timely regulatory approvals for the products
  • Update and collect information on registration instructions and regulations

Requirements:

  • University degree in Life Science field
  • Fluent in English and Hungarian languages
  • 2-3 years’ experience in Regulatory Affairs with medicinal products and medical devices
  • Experience with food supplements and cosmetics is advantage
  • Time management skills
  • Ability to solve problems and make decisions

Benefits:

  • Personal and professional development
  • Additional benefits (bonus system, additional health insurance etc.)
  • International team spirit
  • Remote work
  • Career opportunities
Job Category: Regulatory Affairs
Job Type: Full Time
Job Location: Hungary
Job Specification: R2

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