France Start-Up Regulatory Lead (Hybrid/Remote)

Fortrea; Paris; Hybride; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Collaborative culture

Professional development

Competitive compensation

Flexible working arrangements

Résumé du poste

Fortrea seeks a Start Up Country Lead in France to drive regulatory operations for clinical trials, ensuring compliance, quality, and timely delivery of milestones in a dynamic, global environment.

The role is sponsor-dedicated with a hybrid work model, offering opportunities to lead regulatory submissions, manage cross-functional teams, and mentor junior staff while contributing to SOP development and continuous improvement initiatives.

Qualifications

• 5+ years in clinical research with 2.5+ years in EU-CTR regulatory submissions.
• Scientific background such as Pharmacist, PhD or equivalent.
• In-depth knowledge of regulatory frameworks, clinical trial agreements and compliance.
• Fluent in French with professional English proficiency.
• Strong organizational and communication skills; stakeholder engagement.
• Experience mentoring juniors and sharing knowledge.

Responsabilités

• Lead country-level regulatory submissions and approvals for trial protocols.
• Translate and manage local language materials, including ICFs.
• Liaise with IRB/IEC and Regulatory Authorities for ICH/GCP compliance.
• Manage country deliverables, timelines, and results to meet study commitments.
• Collaborate with cross-functional teams to meet regulatory milestones.
• Oversee local vendors and site staff; ensure regulatory processes are followed.
• Contribute to SOP development and continuous improvement initiatives.

Connaissances

Regulatory submissions

Clinical research

Regulatory knowledge

French & English

Stakeholder engagement

Mentoring

Formation

Pharmacist

PhD

Description du poste

Fortrea seeks a Start Up Country Lead in France to drive regulatory operations for clinical trials, ensuring compliance, quality, and timely delivery of milestones in a dynamic, global environment.

The role is sponsor-dedicated with a hybrid work model, offering opportunities to lead regulatory submissions, manage cross-functional teams, and mentor junior staff while contributing to SOP development and continuous improvement initiatives.