Regulatory Affairs Specialist - Australia

Role Overview

This position involves managing the daily operations and ensuring delivery of comprehensive Global Regulatory Affairs support. Key responsibilities include submission management for clinical trials to Competent Authorities, Ethics Committees, and Regulatory Agencies, as well as research, analysis, and reporting on global regulations and compliance requirements. The role further requires developing stakeholder tools, performing regulatory risk assessments, and providing expert guidance both internally and to external collaborators.

Core Responsibilities

• Coordinate and oversee the routine delivery of regulatory service processes, including preparing regulatory filings, submissions, and revisions involving project teams, third-party vendors, and clinical sites.
• Conduct or support regulatory and safety reviews; develop regulatory tools and training resources; maintain current knowledge of clinical research regulations and industry standards, updating project leaders promptly on significant changes.
• Act as corporate regulatory affairs subject matter expert, delivering advice and guidance on regulatory, ethics, and pharmacovigilance matters to stakeholders.
• Represent the regulatory unit in project meetings, regulatory audits, and client interactions, helping develop educational materials and ensuring client regulatory expectations are fulfilled.
• Monitor regulatory changes affecting clinical research, proposing and implementing corporate regulatory strategies in collaboration with safety and quality assurance teams to ensure compliance with evolving regulations.
• Participate in specialized conferences and meetings to enhance professional knowledge relevant to regulatory affairs.
• Facilitate registration processes by promptly responding to requests and collaborating with project teams to determine applicable regulatory requirements.
• Assist in preparing regulatory submission documents and support summaries.
• Manage project and site documentation ensuring compliance with regulatory standards including proper development, maintenance, revision, archiving, and destruction, alongside stakeholder training on regulatory matters.

Qualifications

• Possess an undergraduate degree with 4-6 years of relevant experience in Clinical Research and Regulatory Affairs.
• Demonstrate substantial knowledge of LATAM clinical trial regulations.
• Fluent in English and Spanish, with strong written and oral communication skills in both languages.

Working Conditions

• This position is home-based.
• Company accommodates applicants with disabilities upon request.

Additional Information

The recruitment process may employ artificial intelligence tools for reviewing applications and assessing information consistency. However, final hiring decisions are made by human evaluators. For more information regarding data processing, please inquire directly.