Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. Su…
Boulogne-Billancourt, Ile-de-France, France · On-site
Mid level
Rejoignez Excelya, une entreprise portée par les valeurs d’Audace, de Bienveillance et d’Énergie, où l’innovation et la collaboration sont au cœur de tout ce que nous faisons. En tant que Infirmière de recherche clinique…
Skills: Clinical Research, Patient Monitoring, Nursing Care, Sample Management, eCRF
About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go ha…
Skills: Medical Writing, Analytical Skills, Data Interpretation, Attention To Detail, English Fluency
About the Job Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go ha…
Skills: Analytical Skills, Data Interpretation, Attention To Detail, English Proficiency, ICH Regulations
Redefine Medical. Empower Innovation. Build with Audacity. Join Excelya as Our Next Medical Star! At Excelya, we don’t just work—we Excelyate. Across 24 countries, 900+ passionate professionals are shaping the future of …
Skills: Medical Writing, Clinical Study Reports, Clinical Evaluation Reports, CTD Submissions, Informed Consent Forms
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Full-time
Posted 36d ago
~40 hrs/week
Responsibilities
Provide expert guidance on Greek regulatory requirements and health authority expectations for clinical trials. Support inspection readiness by assessing risks, reviewing trial conduct, and managing CAPAs.
Requirements
Requires proven experience in Regulatory Affairs within the pharmaceutical or clinical research industry with strong knowledge of Greek regulations. Must have a solid understanding of GCP, GDPR, and experience supporting regulatory audits.
Full job description
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
Support the enhancement of regulatory compliance and inspection readiness for clinical activities in Greece, with a focus on GCP and GDPR requirements. The role will provide local regulatory expertise and operational guidance to support teams ahead of a potential inspection by Greek health authorities.
Duration: 1-3 months (freelance).
Main Responsibilities:
Provide expert guidance on Greek regulatory requirements for clinical trials and local health authority expectations.
Advise internal teams on regulatory strategy and compliance matters.
Share insights and lessons learned from clinical trial submissions to Greek authorities.
Collaborate with local and global stakeholders on regulatory and operational topics.
Assess regulatory and quality risks and support inspection readiness activities.
Anticipate potential inspection findings and prepare responses to authority inquiries.
Review clinical trial conduct, investigator site practices, and monitoring activities.
Support deviation management, root cause analysis, and the development and implementation of CAPAs.
Strong knowledge of Greek clinical trial regulations and local health authority requirements.
Proven experience in Regulatory Affairs within the clinical research or pharmaceutical industry.
Solid understanding of GCP, GDPR, and clinical trial compliance standards.
Experience supporting regulatory inspections, audits, and inspection readiness activities.
Ability to assess regulatory and quality risks and drive remediation plans.
Familiarity with clinical operations, site management, monitoring activities, and CAPA processes.
Excellent stakeholder management and communication skills, with the ability to collaborate across local and global teams.
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here's what makes us unique !
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Expertly delivering clinical trials operations, with care.
Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Founded
2014
Headquarters
Boulogne-Billancourt, Île-de-France
LinkedIn followers
114,088
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by Energy, Care, and Audacity.
Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
Offices: 35, Rue de Paris, Boulogne-Billancourt, Île-de-France 92100, FR · 58 Pindou Street, Nea Filadelfia, Athens, GR · The Millenia Nos 1 & 2 Murphy Road Ulsoor,, Bangalore Karnataka, 560008, IN · 19 bd Eugène Deruelle, Lyon, 69003, FR · 1 Quai du Président Wilson, Bègles, Bordeaux 33130, FR
Opérations cliniquesAffaires RéglementairesBiométrieRédaction MédicalePharmacoviglanceInformation MédicaleContract Research OrganisationBiometrics and Clinical ResearchData ManagementPharmacovigilance
Expertly delivering clinical trials operations, with care.
Industry
Pharmaceutical Manufacturing
Company size
501-1,000 employees
Founded
2014
Headquarters
Boulogne-Billancourt, Île-de-France
LinkedIn followers
114,088
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by Energy, Care, and Audacity.
Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
Offices: 35, Rue de Paris, Boulogne-Billancourt, Île-de-France 92100, FR · 58 Pindou Street, Nea Filadelfia, Athens, GR · The Millenia Nos 1 & 2 Murphy Road Ulsoor,, Bangalore Karnataka, 560008, IN · 19 bd Eugène Deruelle, Lyon, 69003, FR · 1 Quai du Président Wilson, Bègles, Bordeaux 33130, FR
Opérations cliniquesAffaires RéglementairesBiométrieRédaction MédicalePharmacoviglanceInformation MédicaleContract Research OrganisationBiometrics and Clinical ResearchData ManagementPharmacovigilance