Regulatory Affairs Specialist - Part Time - Oncology

Belgium, Belgium

Posted:62 days ago
Location:Belgium, Belgium
Job Ref:BH-33982
Job Type:Contract
Salary:€40 - €60 per hour
Expiry date:2/2/2023
Xplore Life Science are recruiting for a Freelance Regulatory Affairs Specialist to support a new research project with a rapidly expanding CRO. 
Location is fully remote anywhere within BELGIUM. This is a part time role and we expect 1 -2 days per week over the next 6 months. 

  • Provide support of regulatory activities, strategy, and deliverables.
  • Be a specialist in local regulatory requirements, completing a range of activities in accordance with these regulatory requirements
  • Collect documents required for Study Start-up’ Collect, update and maintain Information on country specific and EC regulatory requirements for clinical trials and product approvals
  • Assist and provide support to the clinical study teams in the most effective and efficient manner as designated.
  • Prepare and contribute to marketing authorization submissions and strategies
  • Responsible for the preparation and approval of regulatory packages according to the relevant requirements for regulatory and country and Central EC/IRB submissions
  • Liaise with global project team and field-based local specialists
  • Prepare and approve submission packages for country regulatory, central and local Ethics Committees
  • Participate in cross-functional meetings with project team and client
Essential Requirements:
  • Bachelor of Science or nursing degree
  • Relevant experience in European regulatory affairs and clinical research
  • Excellent knowledge of all relevant regulations Including ICH GCP
  • Experience working within clinical trials from Phase I-III, preferably within Oncology
  • Dutch and English required

Apply now