FSP Start Up Country Lead based in Paris region in France

Are you passionate about clinical research and regulatory excellence Fortrea is seeking a Start Up Country Lead to join our team in France. This role offers a unique opportunity to lead regulatory operations for clinical trials ensuring compliance quality and timely delivery of study milestones in a dynamic and global environment.

This is a sponsor-dedicated opportunity.

Location : clients office 2 days a week (hybrid model remote possibility)

Please note this role is for upcoming future opportunities that may arise at Fortrea.

Key Responsibilities

• Lead country-level regulatory submissions and approvals for assigned clinical trial protocols.
• Translate and manage local language materials including informed consent forms.
• Liaise with IRB/IEC and Regulatory Authorities to ensure compliance with ICH/GCP and local regulations.
• Manage country deliverables timelines and results to meet study commitments.
• Collaborate with cross-functional teams (CRM CRA CTC Finance Legal) to ensure regulatory milestones are met.
• Oversee local vendors and site staff ensuring regulatory processes are properly managed.
• Act as a subject matter expert in regulatory processes and contribute to SOP development and continuous improvement initiatives.

Candidate Profile

• Minimum 5 years of experience in clinical research with at least 2.5 years in regulatory submissions within the EU-CTR environment.
• A scientific background (Pharmacist PhD or equivalent).
• Strong knowledge of regulatory frameworks clinical trial agreements and compliance standards.
• Fluency in French and professional proficiency in English .
• Excellent organizational communication and stakeholder engagement skills.
• Experience mentoring junior staff and contributing to team knowledge building.

What We Offer

• A collaborative and inclusive work culture.
• Opportunities for professional development and career progression.
• Competitive compensation and benefits.
• Flexible working arrangements (remote or office-based).
• The chance to contribute to life-changing research

Ready to Apply
If youre ready to make a meaningful impact in clinical research and regulatory operations wed love to hear from you. Apply today and join a team that values innovation integrity and excellence.

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