Line Manager, Regulatory Affairs

Accountabilities

• 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.

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