Tom Denorme

Senior pharmaceutical leader with 20+ years of international experience across Clinical Development, Regulatory Affairs, Quality Governance and Clinical Operations within global pharmaceutical organisations. Proven track record leading strategic regulatory transformation programmes, including EU CTR, CTIS and Brexit implementation, while driving organisational change and cross-functional collaboration. Combines deep operational expertise with executive leadership, translating complex regulatory requirements into pragmatic business solutions that strengthen compliance, governance and organisational performance.

Head of Quality Assurance / Responsible Person GDP at FEBELCO (2023-01 – 2026-12)

• Accountable for Quality Governance across seven GDP distribution centres, ensuring sustained compliance with Belgian and European GDP legislation.
• Led the transformation and continuous improvement of the multi-site Quality Management System (QMS), strengthening governance, compliance and operational excellence.
• Directed regulatory remediation programmes following Health Authority inspections, leading CAPA implementation, effectiveness monitoring and inspection readiness activities.
• Developed and executed risk-based internal and external audit programmes, driving continuous improvement and organisational maturity.
• Oversaw qualification, performance monitoring and quality governance of more than 800 suppliers, applying a risk-based approach to supplier management and temperature-controlled distribution.
• Established quality performance indicators (KPIs) and executive management reporting to support strategic decision-making and organisational performance.
• Led cross-functional quality initiatives involving Operations, Supply Chain, Information Technology, Regulatory Affairs and external business partners.
• Directed product recalls, deviation management, investigations and Quality Risk Management activities, ensuring patient safety and regulatory compliance.

Head – Regional Regulatory Submission Lead, EMEA at MSD (2015-01 – 2023-12)

• Led the Regional Regulatory Submissions function across the EMEA region, providing strategic leadership for complex regulatory submission programmes.
• Directed cross-functional teams delivering regulatory initiatives across multiple countries within a global matrix organisation.
• Led the implementation of major regulatory transformation programmes, including Brexit preparedness and the European Clinical Trials Regulation (EU CTR) and CTIS implementation.
• Collaborated with external stakeholders and industry associations, including EFPIA and EuropaBio, EMA and EU Commission to support the implementation of the European Clinical Trials Regulation (EU CTR) and CTIS.
• Invited speaker at international regulatory conferences in Spain and Türkiye, and presenter at a global virtual CTIS conference during the COVID-19 pandemic, sharing expertise on EU CTR and CTIS implementation.
• Established governance frameworks, performance metrics and executive reporting to enhance operational oversight and support strategic decision-making.
• Drove process harmonisation, standardisation and continuous improvement across regional regulatory operations.
• Partnered with senior stakeholders across Regulatory Affairs, Clinical Development, Clinical Operations, Quality, Supply Chain and Information Technology.
• Represented the organisation in global governance forums, international steering committees and cross-functional strategic initiatives.
• Mentored and developed high-performing professionals within a complex virtual international matrix organisation.

Senior Specialist Regulatory Affairs / Deputy Qualified Person at MSD (2014-01 – 2015-12)

• Led the preparation and coordination of initial Marketing Authorisation Applications (MAAs) across cross-functional teams
• Managed Health Authority interactions and coordinated responses throughout assessment procedures
• Coordinated preparation and quality review of CTD dossiers with CMC, non-clinical and clinical subject matter experts
• Supported lifecycle management activities, including variations, renewals and labelling changes
• Ensured regulatory compliance with European pharmaceutical legislation and regulatory requirements

Clinical Project Manager / Deputy Qualified Person at MSD (2011-01 – 2014-12)

• Managed Phase I–IV clinical trials in accordance with ICH-GCP and global regulatory requirements
• Provided Quality oversight as Deputy Qualified Person during GMP inspections and regulatory audits
• Led quality investigations, deviation management and CAPA implementation within Clinical Operations
• Oversaw IMP lifecycle management, including storage, distribution and compliant destruction
• Ensured cold chain compliance and quality oversight across international clinical supply activities

Associate Clinical Project Manager at UCB (2010-01 – 2011-12)

• Supported the management and coordination of complex multi-country clinical programmes across an international study portfolio.
• Worked within global cross-functional study teams to support trial planning, execution, milestone tracking and issue resolution.
• Coordinated activities across internal stakeholders, local teams and external partners within a complex global matrix environment.
• Supported clinical trial delivery in accordance with ICH-GCP, study protocols and applicable regulatory requirements.

Senior Clinical Research Associate at ALLERGAN (2009-01 – 2010-12)

• Managed and monitored clinical trial sites across Belgium and the Netherlands, ensuring compliance with study protocols, ICH-GCP and applicable regulatory requirements.
• Supported clinical studies in Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH).
• Oversaw site performance, patient recruitment, data quality and timely resolution of study-related issues.
• Built and maintained strong relationships with investigators, study coordinators and cross-functional study teams.
• Contributed to high-quality clinical trial execution and inspection readiness across two countries.

Clinical Research Associate at SANOFI (2006-01 – 2009-12)

• Monitored clinical trial sites and ensured compliance with study protocols, ICH-GCP and applicable regulatory requirements.
• Managed relationships with investigators and site teams and supported patient recruitment, data quality and timely issue resolution.
• Conducted site initiation, monitoring and close-out activities.
• Contributed to inspection readiness and high-quality clinical trial execution.

Logistics Operator at DHL AVIATION (2004-01 – 2006-12)

• Worked within an international, time-critical aviation logistics environment.
• Developed a strong foundation in operational discipline, complex global supply processes and working effectively under strict timelines.

Master in Biomedical Sciences – Vrije Universiteit Brussel (2003-01 – 2003-12)

Bachelor in Pharmaceutical Sciences – Vrije Universiteit Brussel (2004-01 – 2004-12)