Regulatory Affairs Program Director

24 hours ago

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

We are seeking a highly skilled Regulatory Affairs Program Director to join our team at ProductLife Group. 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 in Europe. Your main tasks will be to:

  • Ensure the project management of the programs, including workload management, resource allocation, performance review, and cost review.
  • Ensure the line management of employees onboarded and dedicated to those programs, including training, individual development plans, salary reviews, and promotions.
  • Ensure that all information circulates from our internal teams to the clients and vice-versa, including communication with clients and key internal stakeholders.
  • Guarantee the good and qualitative delivery of RA services to clients in accordance with agreed timelines.
Requirements

To be successful in this role, you will need:

  • 8+ years of experience in European Regulatory Affairs.
  • Knowledge of EU RA regulations for pharmaceuticals, medical devices, and combination products.
  • Experience in line management, resource management, and invoice management.
  • Fluent English and excellent communication skills.
  • Top-notch organizational skills, proven leadership skills, and business/commercial acumen.
  • Willingness to travel occasionally and good IT skills/knowledge.
  • Pro-active attitude and ability to work on own initiative as well as part of a team.
What We Offer

We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive salary and benefits package.

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