Senior Global Regulatory Scientist
Core
Provide high-level regulatory and scientific expertise to support global development strategies and submissions for new medicines and treatments.
Role type
Senior Global Regulatory Scientist
Builds
Global regulatory strategies, clinical trial applications, briefing books, and major submission components
Domain
Healthcare / Clinical Research / Regulatory Affairs
Required skills
Regulatory affairs expertise, Global clinical development regulations knowledge (FDA, EMA, ICH), Strategic input into clinical development plans, Health authority interaction, Cross-functional project leadership, Mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead development of global regulatory strategies for clinical programmes, Author and review complex regulatory documents, Interpret evolving global regulations and advise on programme design, Provide strategic input into clinical development plans and risk management, Represent regulatory functions in sponsor and health authority meetings, Mentor junior regulatory colleagues
Seniority
Senior, hands-on IC with mentoring responsibilities