Description
We are looking for a Regulatory Affairs Expert for a project to oversee, manage, advise and coordinate the implementation of a new Regulatory Information Management system for regulatory affairs submissions according to the required standards.Tasks:
Management of product data from different sources and converting those into a new IT system in a structured format, by extracting and migrating relevant information into the new system.
Advising teams how to improve submission process by using the new system and what practise has to be implemented to achieve the objectives,
liaising with other departments and coordinating the quality of information which has to be presented to HA for successful submission,
acting as a leader and mentor to other teams and team members,
Requirements:
Prior regulatory affairs experience in particular in MAA ( CP, MRP, DP, NP)
Experience with submission to EU Authority,
Knowledge and experience of regulations and procedures
Knowledge and experience of electronic submissions tools and processes
This is 12 months contract based on site in Switzerland
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.