Regulatory Affairs Specialist (Australia)

Job Summary

Managing day-to-day regulatory affairs activities, the full-time Regulatory Affairs Specialist (Australia) will oversee clinical trial applications, provide regulatory guidance, and ensure compliance with global regulations while working remotely.

Key responsibilities

• Coordinate the delivery of regulatory services, including the compilation of regulatory filings and submissions
• Provide regulatory, ethics, and pharmacovigilance guidance to project stakeholders and represent the unit in project meetings
• Identify changes in regulatory requirements and recommend corporate regulatory strategies to ensure compliance

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