SciPro are currently partnered with an innovative biotech company focused on the development of novel drug candidates that target membrane receptors concentrating on G Protein Coupled Receptors (GPCRs).
The company are dedicated to translate their knowledge and understanding of tumor immunology and immunosuppressive pathways to develop candidates that have the potential to restore the immune response to cancer. They are a fast- growing, agile business who are 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 project teams 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
- 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 email@example.com