Specialist Regulatory Affairs

Are you experienced in Regulatory Affairs regarding drugs and vaccination? Then apply now!

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Wat ga je doen

As Specialist Regulatory Affairs you will ensure compliance with regulatory agency regulations and interpretations. Furthermore you:

  •  Prepares responses to regulatory agencies' questions and other correspondence
  • Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines
  • Are involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides
  • Provide solutions to a variety of problems of moderate scope and complexity
  • Organize and maintain reporting schedules for new drug application and investigational new drug applications

Wat vragen wij

For the position as Specialist Regulatory Affairs you have a bachelor degree or higher and have more than 4 years experience in Regulatory Affairs. Furthermore you:

  • Have experience in dossier development of Module 3 IND/IMPD or MAA/BLA
  • Are able to work in a Documentum System
  • Have hands on dossier development experience
  • Regulatory Affairs CMC guideline knowledge
  • Good communication Skills

Wat hebben we te bieden

  • Secondment via CheckMark Labrecruitment
  • Salary indication from €3.736,- gross per month based on a full-time position
  • Position for 40 hours/week
  • Dayshift

Waar ga je aan de slag

A large pharmaceutical company dedicated to bringing life-saving innovation to global health.

Wil je meer weten?

Sebastiaan Loriaux
088 00 21 126
Na Rae de Jong
088 00 21 123
Vacaturenummer: 6702

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