Regulatory Affairs Specialist (Australia)

About the role

The Regulatory Affairs Specialist will provide day‑to‑day support for global regulatory activities, ensuring clinical trial applications are submitted accurately to competent authorities, ethics committees and regulatory agencies. The role is home‑based and requires close collaboration with internal teams, sponsors and external regulators.

Key responsibilities

• Manage preparation, submission and tracking of clinical trial applications across multiple jurisdictions.
• Research, review and report on global regulatory requirements, with a focus on LATAM regulations.
• Develop stakeholder tools, conduct regulatory risk assessments and create training materials.
• Coordinate regulatory filings, revisions and safety reviews with third‑party vendors and clinical sites.
• Represent the regulatory unit at project meetings, audits and regulatory queries on behalf of clients.
• Identify regulatory changes, propose corporate strategies and participate in relevant conferences.
• Maintain project documentation in compliance with regulatory standards.

Required profile

• Undergraduate degree (any discipline).
• 4–6 years of experience in clinical research or regulatory affairs.
• Strong knowledge of LATAM clinical trial regulations.
• Fluency in written and spoken English and Spanish.

Required skills

What we offer

• Remote work arrangement.
• Opportunity to work on international clinical research projects.
• Professional development through conferences and training.