Our RA teams are looking for a Program Director based in France to pilot and manage our Regulatory Affairs outsourcing projects for two of our major incoming clients for which specific programs and teams will be put in place.
You will act as a direct point of contact with those clients and coordinate several outsourcing projects for their Regulatory Affairs activities (pre-MAA and post-MAA) in Western Europe. You main tasks will be to:
-Hard skills:
· 8+ years experience in French Regulatory Affairs
· Knowledge of French RA regulations for pharmaceuticals (NCEs, Biologicals and Biotech), Medical Devices, Combination products
· Knowledge of EDMS, Regulatory Databases (Register)
· Experience in line management
· Experience in resource management
· Experience in invoice management
· Ideally be a qualified Pharmacist in France to take these responsibilities
· Ideally have Belgium and Western EU Regulatory Affairs experience
-Soft skills
· Fluent French and English mandatory
· Excellent communication skills
· Top-notch organizational skills
· Willingness to travel occasionally
· Good IT skills/knowledge
· Pro-active attitude and ability to work on own initiative as well as part of a team
· Ability to prioritize different workloads/multi-task
· Personal responsibility for ensuring a high standard of work