Regulatory Affairs Program Director M/F

Found in: Talent UK C2 - 1 week ago


Cambridge, United Kingdom ProductLife Group Full time

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


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