Regulatory Affairs Officer – Greece

Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.

We take an one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya’s vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.

Excelya is currently seeking for a qualified candidate to join our Regulatory Affairs team for the position of Regulatory Affairs Officer.

The role:

We are seeking a motivated and detail-oriented Regulatory Affairs Officer to join our Regulatory Affairs team. This role offers an exciting opportunity for recent graduates or early-career professionals to develop their expertise in regulatory processes while working with a diverse range of clients in both pharma and non-pharma industries.

General Responsibilities/Tasks:

• Assist in the preparation, review, and submission of regulatory documents to health authorities, including marketing authorizations, variations, and renewals.
• Support the preparation of product dossiers for pharmaceutical, medical devices, and non-pharma projects.
• Coordinate and track regulatory submissions, ensuring timelines and regulatory requirements are met.
• Stay updated on changes in local and international regulations and ensure compliance for client projects.
• Communicate effectively with clients, internal teams, and health authorities to address regulatory questions and provide timely updates.
• Maintain regulatory databases, archives, and documentation to ensure accuracy and compliance.
• Participate in regulatory strategy discussions and provide input for efficient project execution.