Regulatory Affairs Manager

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.

Requirements

• 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.

Benefits

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.