Line Manager, Regulatory Affairs

• Lead and coordinate regulatory and ethics committee submission activities for clinical trials, ensuring compliance with applicable regulations, quality standards, and project timelines.
• Develop and provide country-specific regulatory strategies, offering expert guidance to internal teams and external stakeholders throughout the clinical trial start-up process.
• Prepare, review, and oversee regulatory submissions, including clinical trial applications, amendments, notifications, informed consent documentation, safety reporting submissions, and other study-specific regulatory packages.
• Act as the primary point of contact for regulatory authorities, ethics committees, sponsors, investigative sites, vendors, and cross-functional teams regarding regulatory matters.
• Review and approve regulatory documentation produced internally or by external partners to ensure accuracy, completeness, and compliance prior to submission.
• Manage regulatory documentation within Trial Master Files (TMF), ensuring timely filing and maintaining inspection readiness throughout the study lifecycle.
• Support regulatory intelligence activities by monitoring evolving regulations and providing expertise on regional and local regulatory requirements, including CTIS processes and EU Clinical Trial Regulation compliance.
• Participate in project meetings, audits, process improvement initiatives, training activities, and cross-functional projects that enhance operational effectiveness and regulatory excellence.
• Provide direct line management to regulatory team members, including onboarding, coaching, performance management, career development, workload planning, and resource allocation.
• Foster a positive and collaborative team culture while contributing to recruitment efforts and driving productivity improvements across the regulatory function.

Requirements

• Bachelor's degree or equivalent qualification in a scientific or life sciences discipline.
• Minimum of 3–5 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, clinical research, or CRO sectors.
• Demonstrated experience preparing and submitting Clinical Trial Applications (CTAs), Ethics Committee submissions, and IRB/IEC packages.
• Strong understanding of European clinical trial regulations, including Regulation (EU) No 536/2014 and CTIS processes at both local and regional levels.
• Knowledge of Good Clinical Practice (GCP) and applicable regulatory frameworks governing clinical research activities.
• Previous people management, team leadership, or functional staff supervision experience is considered an advantage.
• Excellent organizational skills with the ability to manage multiple priorities, meet deadlines, and perform effectively in a fast-paced environment.
• Strong communication, stakeholder management, and collaboration skills, with the ability to provide guidance across diverse teams and clients.
• High attention to detail, analytical thinking, and commitment to delivering quality work.
• Proficiency in Microsoft Office applications.
• Fluency in English, both written and spoken; additional European languages are considered a plus.

Benefits

• Permanent full-time employment.
• Fully remote, home-based working arrangement.
• Flexible work schedule supporting work-life balance.
• Generous vacation and paid time off.
• Ongoing learning, professional development, and career growth opportunities.
• Exposure to international clinical research projects and cross-functional collaboration.
• Supportive, collaborative, and innovation-driven work environment.
• Opportunities to lead and develop high-performing regulatory teams.