Regulatory Affairs Officer
Excelya
full-time
Posted on:
Location Type: Hybrid
Location: Paris • France
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About the role
- 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory dossiers preparationregulatory complianceregulatory strategylabeling reviewaudits preparationdocumentation managementregulatory risk identificationsubmission processesproduct lifecycle managementinterpretation of regulations
Soft Skills
communicationstakeholder managementproblem-solvingorganizational skillsattention to detail