Regulatory Affairs Program Director M/F - 928

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.

About us

Group 10

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:

  • Ensure the project management of the programs (workload management, resource management and allocation, performance and quality review, cost review)
  • Ensure the line management of the employees onboarded and dedicated to those programs (training, individual development plan, salary review, promotion, support)
  • Ensure that all the information circulates from our internal teams to the clients and vice-versa (communication with the clients and key internal stakeholders at PLG)
  • Guarantee the good and qualitative delivery of RA services to the clients in the respect of the agreed timelines

Group 13

-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

Regulatory Affairs Program Director M/F - 928