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Regulatory Affairs Assistant

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#NL30414
Type: Full time

Job Description

  • Compilation of technical dossiers (Modules 1, 2.3, 3) for new development pharmaceutical products
  • Update existing technical dossiers of pharmaceutical products, in order to comply with current EU requirements or other country specific requirements (for non-EU registrations)
  • Preparation and submission of registration files to the competent authorities for new product applications, variations, notifications, renewals
  • Handling correspondence with the competent authorities
  • Filling-in & keeping up-to-date company databases with registration information


Candidate’s profile

  • University degree (preferably in Pharmacy, Chemistry or Biology)
  • 2-3 years of experience in a similar position will be considered an asset (CMC, registration procedures)
  • Excellent command of the English language
  • Computer literacy


The company offers

  • Continuous training and opportunities for professional growth
  • Friendly and challenging working environment
  • Competitive benefits package


All candidates will be treated in strict confidentiality

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