Regulatory Affairs Program Director M/F - 080

Our RA teams are looking for a Program Director based in the UK to pilot and manage Regulatory Affairs outsourcing projects/programs for major clients for which specific dedicated programs and teams are put in place.

About us

Group 10
Missions

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 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
Profile

-Hard skills:

· 8+ years experience in European Regulatory Affairs

· Knowledge of EU 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

 

-Soft skills

· Fluent English mandatory

· Excellent communication skills

· Top-notch organizational skills

· Proven leadership skills

· Business/Commercial acumen

· 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

· Personal responsibility to ensure a high standard of work

Regulatory Affairs Program Director M/F - 080

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