RESPONSABILITIES
In the context of team expansion, we are looking for a new experienced Regulatory figure to join our dynamic international teams for the following missions :
- Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements for the Nordic Countries
- Gain regulatory authority approval and liaise with the authorities
- 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 Officers and Associates