Regulatory Affairs Manager – Regulatory Liaison

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

📋 Description

• Act as the main regulatory representative within designated clinical trial teams.

• Organize and oversee regulatory activities that support global clinical development initiatives.

• Prepare, review, compile, and coordinate regulatory submission packages.

• Ensure that submissions are accurately completed and delivered within set timelines.

• Monitor regulatory milestones and submission statuses while overseeing regulatory deliverables.

• Keep thorough and inspection-ready regulatory documentation throughout the clinical trial lifecycle.

• Collaborate with Clinical Operations, Medical Affairs, Regulatory Strategy, Start-Up, Document Management, and other cross-functional teams.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific field.

• An advanced degree (Master's or equivalent) is preferred.

• At least 5 years of experience in the pharmaceutical, biotechnology, CRO, or clinical research sectors.

• A minimum of 3 years of experience in Regulatory Affairs supporting clinical trials.

• Experience in preparing and coordinating global regulatory submissions.

• Proven track record of working within cross-functional global project teams.

• Strong knowledge of global clinical trial regulations.

• Familiarity with regulatory requirements for clinical trial start-up and lifecycle.

• Exceptional organizational and planning abilities.

• Capability to handle multiple studies and prioritize competing demands.

• Outstanding attention to detail.

• Ability to interpret complex regulatory requirements and translate them into actionable operational activities.

• Proficient in using electronic regulatory submission systems, CTMS, eTMF/EDMS, and the Microsoft Office Suite.

🏝️ Benefits

• Opportunities for ongoing learning and career advancement.

• A culture that is inclusive, collaborative, and innovative.