FSP Start Up Country Lead based in Paris region in France

Fortrea; Paris; Hybride; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A clinical research organization in Paris is seeking a Start Up Country Lead to oversee regulatory operations for clinical trials. The ideal candidate will have over 5 years of clinical research experience, including regulatory submissions. Responsibilities include leading submissions, managing timelines, and ensuring compliance. This role offers competitive compensation and a hybrid work model.

Prestations

Collaborative work culture

Opportunities for professional development

Flexible working arrangements

Competitive compensation and benefits

Qualifications

• Minimum 5 years of experience in clinical research with at least 2.5 years in regulatory submissions.
• Strong knowledge of regulatory frameworks and compliance standards.
• Experience mentoring junior staff.

Responsabilités

• Lead country-level regulatory submissions and approvals for clinical trial protocols.
• Manage country deliverables timelines to meet study commitments.
• Collaborate with cross-functional teams to ensure regulatory milestones are met.

Connaissances

Regulatory operations

Clinical research

Stakeholder engagement

Communication skills

Fluency in French

Professional proficiency in English

Formation

Scientific background (Pharmacist, PhD or equivalent)

Description du poste

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: client 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 you're ready to make a meaningful impact in clinical research and regulatory operations, we'd love to hear from you. Apply today and join a team that values innovation, integrity and excellence.

Learn more about our EEO & Accommodations request here.

Key Skills

• Anti Money Laundering
• Access Control
• Content Development
• Flex
• AC Maintenance
• Application Programming

Employment Type: Full-Time

Experience: 5+ years

Vacancy: 1