Regulatory Affairs Specialist – North America, LATAM, EU

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

📋 Description

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

• This role involves managing clinical trial applications submitted to Competent Authorities, Ethics Committees, and Regulatory Agencies, along with researching, reviewing, and reporting on relevant global regulations and requirements.

• Create stakeholder tools, process and document regulatory risk assessments, and offer support, expertise, while representing the unit alongside other functional teams, sponsors, researchers, and/or regulatory bodies.

• Ensure the maintenance of high-quality, timely service delivery processes in alignment with corporate, industry, and regulatory standards and guidelines.

• There may be a requirement to mentor peers and/or contribute to staff performance evaluations.

⛳️ Requirements

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

• The ideal candidate will have a strong understanding of LATAM clinical trial regulations.

• Proficiency in both English and Spanish (written and spoken) is essential.

🏝️ Benefits

• Home-based

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