In the context of a new project for one of our top Pharma client, we’re looking for a talented consultant to lead the following missions, and much more!
- Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
- Gain regulatory authority approval
- Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
- Provide regulatory support to clients and associate companies
- Liaise with external regulatory authorities as required
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling
- Review tasks for, support and mentor Regulatory Affairs Associates