Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to join our team in Brussels. You will serve as the primary contact with investigative sites during study maintenance and site startup activities. Your main responsibility will be to collect required investigator and regulatory essential documents to ensure submissions to EC/IRB/Third body/Regulatory Authority are made within agreed timelines.

Key Responsibilities:

• Develop awareness of regulatory legislation, guidance, and practice in assigned countries with senior staff support
• Assist senior staff in compiling, preparing, submitting, and obtaining approval of submission documents to IRB/IEC/Third body/Regulatory Authority
• Liaise with internal and external vendors for Regulatory Authority submissions
• Review final submission documents as applicable
• Organize communication related to submissions/outcomes within Fortrea
• Escalate study issues in a timely fashion
• Perform other duties as assigned by management

Country-specific tasks:

• Serve as primary contact for investigative sites and ensure timely collection of required documents
• Collect and track necessary documents, perform quality reviews, formatting, and compilation of final documents for site activation and maintenance
• Ensure compliance with client expectations, ICH/GCP, SOPs, budget, quality, and applicable laws
• Update study documents when there are changes in study personnel/study amendments
• Ensure high-quality documents are filed and systems are updated on an ongoing basis
• Update status reports, logs, and tracking systems as applicable
• Adapt Informed Consent Forms and patient-facing materials to country-specific requirements
• Support contract negotiation processes under supervision
• Identify and escalate risks to meeting deliverables
• Notify Submissions Lead of out-of-scope hours or overburn

CTIS tasks (EU):

• Upload submission documentation to CTIS under supervision

Requirements:

• University/College degree in life sciences or related field, or certification in a related allied health profession
• 0-2+ years of experience or equivalent combination of education and experience
• Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines
• Basic understanding of the clinical trial process