Regulatory Affairs Principal Specialist – Regulatory Liaison

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Act as the representative for Regulatory Affairs during Clinical Trial Teams and cross-functional meetings.

• Function as the primary regulatory liaison for clinical trial-related issues between argenx and its partners.

• Prepare, assess, and coordinate regulatory submission packages, which include CTAs, amendments, IBs, and IMPDs.

• Guarantee timely and precise submissions that comply with EU CTR and additional regional regulations.

• Supervise delegated tasks and manage regulatory deliverables.

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

• Collaborate with Transparency Leads/Liaisons on disclosure obligations.

• Maintain precise documentation and tracking of regulatory activities.

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

• Work alongside Regulatory Scientists, Regulatory Coordinators, and external partners to streamline workload efficiency.

• Direct strategic regulatory initiatives for medical devices, in-vitro diagnostics, and clinical research services.

• Engage with global health authorities to ensure submission quality excellence across different jurisdictions.

⛳️ Requirements

• Master's degree in a scientific discipline or equivalent experience and education.

• Over 8 years of relevant experience demonstrating necessary knowledge, skills, and competencies.

• At least 5 years of experience in a similar Regulatory Liaison role.

• Preferred academic backgrounds include Life Sciences, Chemistry, Biology, Pharmacy, or other related scientific fields.

• Professional certification in Regulatory Affairs (RAC) is advantageous.

• In-depth knowledge of global regulations, including FDA, EU MDR/IVDR, and ICH guidelines.

• Expert understanding of regulatory submission requirements.

• Significant experience in managing regulatory submissions and interactions with agencies.

• Advanced project management and organizational capabilities.

• Proven leadership skills with experience in managing regulatory and cross-functional teams.

• Excellent written and verbal communication abilities.

• Strong interpersonal skills for effective cross-functional collaboration.

• Strong analytical and problem-solving skills.

• Proficient in regulatory submission tools and documentation systems.

• Experience with quality management systems and GMP regulations.

• Knowledge of clinical trial regulations and requirements.

• Ability to interpret and apply new regulatory requirements.

• Willingness and capacity to travel 10–20% of the time.

• Proficiency in English is essential; additional languages are a plus.

🏝️ Benefits

• Fully remote work arrangement.

• Reasonable accommodations for individuals with disabilities.

• Additional benefits and privileges of employment (details not specified).