Regulatory Affairs Program Director

1 month ago

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

ProductLife Group is seeking a highly skilled Regulatory Affairs Program Director to lead our outsourcing projects/programs for major clients in the UK.

As a key member of our team, you will be responsible for managing Regulatory Affairs outsourcing projects/programs, ensuring timely delivery of high-quality services to clients. Your expertise in EU RA regulations, EDMS, and Regulatory Databases will be invaluable in this role.

About the Role

Key responsibilities include:

  • Project management of outsourcing programs, ensuring workload management, resource allocation, and performance review.
  • Line management of employees onboarded to programs, including training, individual development plans, and performance evaluations.
  • Effective communication with clients and internal stakeholders to ensure seamless information exchange.
  • Guaranteeing the delivery of high-quality RA services to clients within agreed timelines.
Requirements

To succeed 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, leadership skills, and business acumen.
  • Pro-active attitude and ability to work independently and as part of a team.
What We Offer

As a Regulatory Affairs Program Director at ProductLife Group, you will have the opportunity to work on high-profile projects, develop your skills, and contribute to the growth of our company.

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