Regulatory Submissions Specialist — France (Clinical Trials)

Medpace; Lyon; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading clinical research organization in Lyon is seeking a full-time Regulatory Submissions Coordinator to join their Clinical Operations team. This position is crucial for managing clinical trial submissions in compliance with regulations. The ideal candidate will possess a Bachelor's degree in Life Sciences, have 4-5 years of relevant experience, and be fully proficient in both French and English. You will prepare and review submissions, and ensure regulatory compliance while maintaining excellent organizational and communication skills.

Qualifications

• Bachelor's degree (preferably in a Life Sciences field) required.
• 4-5 years of experience as a Regulatory Submissions Coordinator needed.
• Hands-on experience with regulatory documentation is necessary.

Responsibilities

• Prepare and file clinical trial applications for France.
• Submit responses to queries and amendments for applications.
• Advise team on changing regulations and compliance requirements.

Skills

Regulatory documentation preparation

Bilingual in French and English

Organization skills

Attention to detail

Education

Bachelor's degree in Life Sciences

Tools

Microsoft Office

Job description

A leading clinical research organization in Lyon is seeking a full-time Regulatory Submissions Coordinator to join their Clinical Operations team. This position is crucial for managing clinical trial submissions in compliance with regulations. The ideal candidate will possess a Bachelor's degree in Life Sciences, have 4-5 years of relevant experience, and be fully proficient in both French and English. You will prepare and review submissions, and ensure regulatory compliance while maintaining excellent organizational and communication skills.