Hybrid Regulatory Affairs Officer

at Excelya

• Job title: Regulatory Affairs Officer
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Paris, France

About the role

• Regulatory Affairs Officer ensuring compliance and supporting regulatory strategies within an ambitious team at Excelya. Contributing to the development and maintenance of innovative health products in a dynamic environment.

Responsibilities

• Prepare, compile, and submit regulatory dossiers (initial submissions, variations, renewals, responses to authorities’ questions).
• Ensure compliance of documentation and activities with applicable regulations (EU, ICH, national authority guidelines).
• Support regulatory strategy throughout product lifecycle (development, registration, post‑approval).
• Interface with health authorities, ethics committees, and internal/external stakeholders.
• Track regulatory timelines, approvals, and commitments to ensure smooth project progression.
• Review and validate labeling, artwork, SmPC/PIL, and promotional materials as per regulatory standards.
• Participate in the preparation of audits and inspections related to regulatory aspects.
• Maintain accurate documentation and records in line with internal SOPs and regulatory requirements.
• Identify regulatory risks and propose solutions or mitigation strategies.

Requirements

• Experience: Prior experience or solid knowledge in regulatory affairs within the pharmaceutical, biotech, or medical device sector is essential.
• Skills:
• Understanding of regulatory frameworks and submission processes (EU, EMA, national agencies).
• Familiarity with product lifecycle management (development → registration → post‑marketing).
• Ability to interpret regulations and provide clear guidance to operational teams.
• Education: Bachelor's degree in life sciences, pharmacy, or a related scientific discipline (or equivalent qualification).
• Languages: Fluent in French and English (written and spoken).

Benefits

• At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
• 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.