Specialist Regulatory Affairs

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

Het is niet meer mogelijk om te solliciteren op deze vacature. Back to overview

What will your job be

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

What are we looking for

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

What do we offer

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

Where will you work

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

More information

Sebastiaan Loriaux
088 00 211 26
Na Rae de Jong
088 00 211 23
Ref.nr: 6702
Het is niet meer mogelijk om te solliciteren op deze vacature.