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Regulatory Affairs

2 weeks ago


France, United Kingdom SciPro Full time

growing, agile business whoare looking for a Regulatory Affairs & Quality Assurance Manager to join their Development Department based in France.

You will be responsible for the development and execution of the regulatory strategy as well as the implementation of the quality system for development activities. Within the role you will work closely with the Development department as well as projectteams across the business.

The role will include:

- Develop regulatory strategy and advise on EU and North American submissions
- Liaise with CRO regulatory team
- Implement and monitor timelines for submissions
- Actively identify potential issues and be the main point of escalation
- Implement and manage QMS
- Ensure personnel are trained and implements procedure to track training

Ideal requirements:

- Master's degree in Regulatory Affairs or another scientific discipline
- Minimum 8 years of experience involving positions in both Regulatory Affairs and Quality Assurance
- Experienced in liaising with European agencies and the FDA for clinical studies submissions and interactions for scientific advice
- Highly adaptable with an ability to manage various tasks with competing priority

If you are interested, please send your CV to