Regulatory Affairs Specialist

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.

Provide operational regulatory support to a pharmaceutical affiliate in Greece, with primary responsibility for the maintenance and lifecycle management of national Marketing Authorisations (MAs), particularly for an oncology product. The role also supports regulatory activities across several European distributor markets.

Main Responsibilities:

• Manage the lifecycle of MAs and ensure regulatory compliance.
• Prepare, submit, and track regulatory variations, renewals, and post-approval changes.
• Support new Marketing Authorisation applications when required.
• Review and maintain product information and regulatory documentation.
• Approve local translations, labelling, packaging, and artwork materials.
• Coordinate regulatory activities with affiliates, distributor markets, and global teams.
• Partner with cross-functional teams and provide support for Quality/GDP activities when needed.

Requirements

• Degree in Pharmacy, Life Sciences, Biology, Chemistry, or a related scientific field.
• At least 3 years of Regulatory Affairs experience in the pharmaceutical industry.
• Experience with submissions, variations, renewals, and MA lifecycle management.
• Strong knowledge of European pharmaceutical regulations and regulatory processes.
• Understanding of product information, labelling, and regulatory documentation requirements.
• Strong organizational, project management, and stakeholder communication skills.
• Fluent Greek and English
• Oncology, GDP, or Quality Assurance experience is a plus.

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.