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).

Group 10
Your missions

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

Group 13
Your profile

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

Western EU Regulatory Affairs Team Lead - 670