Regulatory Affairs Specialist

Job Summary

Managing the day-to-day activities of Global Regulatory Affairs support services, the full-time remote Regulatory Affairs Specialist (LATAM) will oversee clinical trial applications, provide regulatory guidance to stakeholders, and ensure compliance with evolving regulations.

Key responsibilities

• Coordinate regulatory services, including the compilation of regulatory filings and submissions for projects and clinical sites
• Provide regulatory, ethics, and pharmacovigilance support to project stakeholders and represent the unit in project meetings
• Identify changes in regulatory requirements and recommend corporate strategies to maintain compliance with industry best practices

Required qualifications

• Minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs
• Strong knowledge of LATAM clinical trial regulations
• Fluency in English and Spanish (written and verbal) required