Responsibilities

The Global Reg Affairs Lead will provide regional lead review and technical advice for regulatory submissions, ensuring high quality standards and meeting client and regulatory requirements. They will serve as a subject matter expert, offering regulatory strategy advice and technical expertise to clients and internal stakeholders. The role involves monitoring legislation, ensuring quality performance for key projects, managing project budgets, identifying out-of-scope activities, reviewing protocols and ICFs, acting as a point of contact for Health Authorities, collaborating with business development on pricing and securing new business, providing matrix leadership and training, overseeing RALs, and participating in launch and review meetings.