Regulatory Affairs Specialist (Australia)

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