ICON seeks a Senior Global Regulatory Scientist to provide regulatory and scientific guidance on clinical development programmes and submissions across multiple regions. The role involves leading regulatory strategies, authoring complex submissions, and mentoring junior colleagues from a home-based position in Mexico.
Responsibilities
Lead development of integral regulatory strategies for clinical programmes and health authority interaction plans
Author and review complex regulatory documents including trial applications and submission components
Interpret global regulations and guidelines; advise teams on implications for programme design
Represent regulatory function in sponsor and health authority meetings with scientific communication
Mentor junior regulatory colleagues and establish best practices and knowledge-sharing initiatives
Requirements
Bachelor's degree in relevant scientific or healthcare field
Extensive regulatory affairs experience in pharma, biotech, or CRO settings
Strong knowledge of FDA, EMA, ICH, and regional clinical development regulations
Excellent scientific, analytical, and critical-thinking capabilities with attention to detail
Proven health authority interaction and cross-functional project leadership experience
Outstanding written and verbal communication skills
Willingness to travel approximately 10% as required
📌 Senior Global Regulatory Scientist (Xico)
🏢 Icon
📍 Xico