Cure Talent are delighted to be partnered with a global CDMO specialising in complex drug-device combination products, as they continue to expand their Regulatory Affairs capability following a period of significant growth.
As part of an ongoing reorganisation, the business is growing its regulatory team and appointing Regulatory Manager to lead project delivery across a diverse portfolio of combination products, with a strong focus on inhalation and respiratory devices. This is a client-facing, hands-on leadership role where you will be responsible for driving regulatory strategy and delivery across multiple projects, acting as the regulatory subject matter expert and primary point of contact for customers and regulatory agencies.
As the Regulatory Manager, you will lead the regulatory aspects of development programmes, contributing to project planning, advising on regulatory pathways and ensuring high-quality submission content, with particular focus on Module 3 authoring. You will work closely with internal teams and external clients, providing clear, confident regulatory guidance and challenging where required to ensure compliant and efficient routes to market.
This role combines leadership with delivery. While you will have responsibili...