Senior Global Regulatory Scientist

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 global 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