Argenx

Regulatory Operations Specialist

05/03/20

Location

NULL NULL, Zwijnaarde, 9052, Ghent

Function type

Clinical research

Vacancy

The position will have the following key responsibilities:
  • Responsible for the preparation, quality control, and delivery of components of regulatory submissions including clinical trial applications (EudraCT forms), protocol amendments, scientific advice briefing documents, Investigator’s Brochures, IMPD’s and IND’s, and other submissions
  • Prepare and review and follow-up of answers to questions from regulatory authorities
  • Responsible for activities related to regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
  • Archiving of regulatory documents, submissions, queries, approvals and correspondence, in accordance with the requirements
  • SOP management: Identify the need for new SOP’s , draft new SOP’s and maintain existing SOP’s
  • Maintain the regulatory folders on SharePoint and be a key user of SharePoint

Job application