Regulatory Affairs Program Director

4 weeks ago

Cambridge, Cambridgeshire, United Kingdom ProductLife Group Full time
Regulatory Affairs Program Director

At ProductLife Group, we are seeking a highly skilled Regulatory Affairs Program Director to join our team in the UK. As a key member of our Regulatory Affairs team, you will be responsible for piloting and managing Regulatory Affairs outsourcing projects/programs for major clients.

About the Role

You will act as a direct point of contact with clients and coordinate several outsourcing projects for their Regulatory Affairs activities (pre-MAA and post-MAA) in Europe. Your 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

About You

We are looking for a candidate with 8+ years of experience in European Regulatory Affairs, knowledge of EU RA regulations for pharmaceuticals (NCEs, Biologicals and Biotech), Medical Devices, Combination products, and experience in line management, resource management, and invoice management. You should also have excellent communication skills, top-notch organizational skills, proven leadership skills, business/commercial acumen, and a willingness to travel occasionally.

What We Offer

We offer a competitive salary, a dynamic and supportive work environment, and opportunities for professional growth and development. If you are a motivated and experienced Regulatory Affairs professional looking for a new challenge, please submit your application.

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