Regulatory Affairs Associate

The Regulatory Affairs Associate will support the regulatory, ethical, and data governance aspects of academic and investigator-initiated clinical research projects at CIEC. The role contributes to the preparation, submission, and follow-up of regulatory and ethics applications, while ensuring methodological and regulatory compliance throughout the study lifecycle. The ideal candidate is detail-oriented, proactive, and motivated to enhance the quality and integrity of academic clinical research. The Regulatory Affairs Associate will work at LIH’s Clinical and Epidemiological Investigation Center (CIEC).

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 collaborative research initiatives, including European consortia and grant applications, by providing regulatory input where needed.

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 and investigator-initiated trials is considered an 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.
• 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.