Clinical Research Regulatory Officer

The Clinical Research Regulatory Officer will support the regulatory, ethics, and data governance aspects of academic and investigator-initiated clinical studies coordinated by the Clinical & Epidemiological Investigation Center (CIEC). The role focuses on the preparation, submission, and follow-up of applications to the Competent Authority and the National Ethics Committee in Luxembourg, ensuring methodological and regulatory compliance throughout the study lifecycle. The position is embedded in an academic research environment (not pharmaceutical product registration) and requires a solid understanding of clinical research methodology (including the difference between interventional vs. non-interventional studies) and of national/EU frameworks applicable to non-commercial research. The role is performed under the supervision and in close collaboration with the Clinical Research Coordinator Quality & Regulatory.

Regulatory & Ethics Submissions

• Provide regulatory input during study design and feasibility stages to ensure methodological robustness and ethical soundness in line with applicable legislation and institutional standards.
• Contribute to the drafting and review of study documentation, including protocols, informed consent forms, and other regulatory documents, to ensure accuracy and compliance with submission requirements.
• Prepare and submit regulatory and ethics application packages to the Competent Authority (CA) and the National Ethics Committee (EC) for sponsor-driven, academic, and translational research projects.
• Ensure submissions are complete, accurate, and aligned with national and EU regulatory requirements as well as internal procedures.
• Coordinate responses to queries from the CA and the EC, ensure timely follow-up, and track approvals to maintain project timelines.

GDPR & Data Governance Support

• Assist in ensuring compliance with GDPR, data protection requirements, and provisions governing the secondary use of data and biological samples in clinical research.
• Support the development and review of data protection documentation, including data processing records, data-sharing agreements, and participant information materials addressing privacy aspects.
• Liaise with the Data Protection Officer (DPO), institutional legal teams, and project stakeholders to ensure alignment on data governance and confidentiality requirements.

Documentation & Quality

• Provide specialised expertise in clinical research regulations and documentation standards.
• Maintain complete and up-to-date regulatory files, submission trackers, approvals, and correspondence within CTMS/eTMF systems, and ensure accurate reporting in project management tools.
• Contribute to the development, implementation, and continuous improvement of WIs, SOPs, templates, and regulatory workflows to support quality and compliance.

Internal Coordination

• Collaborate closely with principal investigators, researchers, legal and data protection offices, clinical project managers, and hospital partners to ensure regulatory alignment across all study activities.
• Provide clear guidance and practical support to project teams on regulatory requirements, submission standards, and documentation practices.
• Participate in internal meetings, training sessions, and knowledge-sharing initiatives to promote regulatory awareness and continuous improvement.

Key Accountabilities

• Act as a liaison between investigators, institutional offices, hospital partners, and regulatory authorities to ensure alignment on regulatory and ethical requirements.
• Support the overall regulatory compliance and quality assurance framework within CIEC.
• Contribute to internal capacity building and training in regulatory best practices for academic and non-commercial studies.

Key Skills, Experience and Qualifications

• Master’s degree in Medical, Health, Biomedical or Life Sciences, or in a related field (e.g. Biology, Biotechnology).
• Certified training in clinical research (e.g. DIU-FARC, DIU-TEC, or equivalent).
• At least 2 years of experience in regulatory affairs, clinical research administration, or a related role within a CRO, clinical trial unit, research centre, or the pharmaceutical industry.
• Experience with academic or investigator-initiated trials is considered a strong asset.
• Solid understanding of EU and Luxembourg research regulation frameworks, including patient rights, data protection (GDPR), Clinical Trial Regulation (CTR), and procedures of the CA and EC.
• Ability to differentiate between interventional and non-interventional study types and related submission pathways.
• Familiarity with EU and international regulatory frameworks for clinical research, data protection, and the secondary use of data and samples (e.g. CTR, GDPR, ICH-GCP, MDR).
• Strong analytical and writing skills, with the ability to summarise complex information and set clear priorities.
• Excellent attention to detail, organisational and document management skills.
• Proven ability to work independently and collaboratively within multidisciplinary teams.
• Positive interpersonal skills and the ability to interact confidently with investigators, advisors, and regulatory authorities.
• Fluent in French and English; knowledge of other commonly spoken languages in Luxembourg (Portuguese, German, Luxembourgish) is an advantage.