Regulatory Liaison

This is a fully remote position, open to applicants in Belgium, +1 more country.

📋 Description

• Act as a representative for Regulatory Affairs within Clinical Trial Teams (CTTs) and during cross-functional meetings.

• Function as the primary contact for regulatory matters concerning clinical trials between argenx and its partners.

• Prepare, review, and coordinate regulatory submission packages, which include CTAs, amendments, IBs, and IMPDs, in collaboration with partners.

• Ensure submissions are timely and accurate, adhering to EU CTR and other regional regulations.

• Oversee delegated activities and maintain supervision of regulatory deliverables.

• Guarantee compliance with both global and local regulatory standards as well as company SOPs.

• Work with the Transparency Lead and Liaisons to ensure adherence to disclosure mandates.

• Keep precise documentation and tracking of all regulatory activities.

• Participate in process enhancements and the application of best practices within CTR Excellence.

• Collaborate closely with Regulatory Scientists, Regulatory Coordinators, and External Partners to streamline workload.

⛳️ Requirements

• A Bachelor’s degree in a relevant scientific discipline or a healthcare-related field.

• Essential experience in Regulatory submissions and a strong background in EU CTR.

• Proven experience working within cross-functional teams.

• Comprehensive knowledge of EU Clinical Trial Regulation (CTR) and global regulatory frameworks.

• Capability to manage complex tasks, prioritize effectively, and adhere to tight deadlines.

• Strong attention to detail.

• Proactive collaboration in alignment with operating principles to advance assignments.

• Ability to interpret regulatory guidelines and implement them in operational processes.

• Sound judgment with the ability to evaluate situations and information critically.

• Make decisions based on facts and data rather than assumptions.

• Legal authorization to work in the country where the position is offered.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.