Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Australia.

📋 Description

• Accountable for the daily operations and provision of Global Regulatory Affairs support services.

• The position entails managing clinical trial submissions to Competent Authorities, Ethics Committees, and Regulatory Agencies.

• Conduct research, review, and report on relevant global regulations and requirements.

• Create tools for stakeholders and document regulatory risk assessments.

• Offer support and expertise while representing the unit in interactions with other functional units, sponsors, researchers, and regulatory authorities.

• Ensure that high-quality, timely service delivery processes are upheld in alignment with corporate, industry, and regulatory standards and guidelines.

• May be tasked with coaching colleagues and/or contributing to staff performance evaluations.

⛳️ Requirements

• Candidates should hold at least an undergraduate degree and possess 4-6 years of pertinent experience in Clinical Research/Regulatory Affairs.

• The ideal applicant will demonstrate a strong understanding of LATAM clinical trial regulations.

• Proficiency in both English and Spanish (written and verbal) is required.

🏝️ Benefits

• Home-based

• *Accommodations for job applicants with disabilities are available upon request.