Regulatory Submissions Coordinator

Regulatory Submissions Coordinator

Company: Global Clinical Research Organisation (CRO)

Reports to: Regulatory Submissions Manager

Location: Lyon, France

Role Overview

One of the world's largest Clinical Research Organisations (CRO) is seeking a new Regulatory Submissions Coordinator join their Regulatory Submissions Team in France.

You will be responsible for the management and implementation of Regulatory strategy in relation to the coordination of Regulatory submissions for Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

An independent, organised, and dependable individual is required to ensure there is a strong professional focus on the delivery of this role on a regional level.

Flexible working from home policy available.

Key Responsibilities

• Review the submissions and coordinate the preparation of Regulatory documents for Clinical Trial Applications to Regulatory Agencies
• Deliver Regulatory understanding on Regulatory submissions
• Guarantee Regulatory submissions adhere to international Regulatory compliances
• Manage the Regulatory submissions are submitted in a time-effective manner

Essential Criteria

• Life Science Degree
• Regulatory experience in a Clinical environment
• Knowledge of ICH and EMA regulatory guidelines
• Strong interpersonal and communication skills
• Fluent in French and English

Benefits

• Competitive salary for Lyon
• Bonus
• Pension/Health

Process

• Screening call with Life Science People
• First interview with Talent Acquisition
• Second interview with Hiring Manager
• Offer
• 2-3 week process

For further information or to apply directly, please send a copy of your CV and your availability for a video conference to;