Line Manager, Regulatory Affairs

Job description

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. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Line Manager, Regulatory Affairs in Romania. Join a dynamic clinical research environment where you will play a pivotal role in advancing clinical trial start-up activities across Europe. This position combines hands-on regulatory expertise with people leadership, offering the opportunity to drive both operational excellence and team development. You will oversee regulatory and ethics submissions, guide project teams on compliance strategies, and ensure timely execution of critical regulatory milestones. Working in a remote and collaborative setting, you will contribute to high-impact clinical research programs while mentoring and supporting a team of regulatory professionals. This role is ideal for a regulatory affairs specialist who enjoys balancing strategic oversight, stakeholder engagement, and leadership responsibilities in a fast-paced international environment.