Our RA teams in Western Europe are looking for a Team Lead to manage our Regulatory Affairs teams based in France and BeNeLux (15 people).
Our RA teams in Western Europe are looking for a Team Lead to manage our Regulatory Affairs teams based in France and BeNeLux (15 people).
You will act as a direct point of contact for our clients on several outsourcing projects for their Regulatory Affairs activities (pre-MAA and post-MAA) in France and BeNeLux. You main tasks will be to:
· Ensure the line management of the team members (workload management, performance review, skills improvement, training plans, promotion)
· Ensure that all the information circulates from/to/within the team.
· Make the communication link between the team and the other Regulatory Affairs local teams
· Guarantee the good and qualitative delivery of RA services to the clients
Hard skills:
· 5+ 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
· Would be bonus to have Belgium and Western EU Regulatory Affairs experience
Soft skills:
· Fluent English mandatory
· Excellent communication skills
· Top-notch organizational skills
· 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