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IQIQVIA

Regulatory Affairs Specialist(m/w/x)

Wien
Full-timeOn-siteExperienced

Coordinating submissions for medicinal products to local Health Authorities for healthcare clients. 3+ years EU experience with medicinal product legislation in DACH region required. Work in a large, data-driven organization focused on healthcare solutions.

Requirements

  • Bachelor’s degree in Life Sciences or equivalent professional background
  • 3+ years of experience in EU regulatory affairs for medicinal products
  • Experience within a large regulatory organization
  • Knowledge of pharmaceutical legislation and regulatory requirements in Germany, Switzerland, and Austria
  • Excellent organizational skills and attention to detail
  • Strong communication skills and collaborative working style
  • Fluent written and verbal communication skills in German and English
  • Strong computer skills, including MS Office; experience with regulatory information systems and artwork tools

Tasks

  • Manage regulatory activities for medicinal products
  • Ensure compliance with local requirements
  • Prepare and coordinate regulatory submissions
  • Collaborate with stakeholders on notifications, renewals, variations, and new applications
  • Lead submission processes with local Health Authorities
  • Follow up on submissions until approval
  • Prepare and translate product labeling into German
  • Review and approve artwork and promotional materials
  • Support regulatory maintenance for multiple pharmaceutical products
  • Monitor local pharmaceutical legislation and apply updates

Work Experience

  • 3 years

Education

  • Bachelor's degree

Languages

  • GermanBusiness Fluent
  • EnglishBusiness Fluent

Tools & Technologies

  • MS Office
  • regulatory information systems
  • artwork tools
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of IQVIA and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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