FSP Start Up Country Lead based in Paris region in France

il y a 2 semaines


RueilMalmaison, Île-de-France Fortrea Temps plein

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's 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.

LI-Hybrid #LI-LC1

Learn more about our EEO & Accommodations request here.


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