Regulatory Affairs Specialist – North America

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 encompasses the management of clinical trial submissions to Competent Authorities, Ethics Committees, and Regulatory Agencies.

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

• Develop tools for stakeholders and process/document regulatory risk assessments.

• Offer support and expertise while representing the unit with other functional teams, sponsors, researchers, and/or regulatory bodies.

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

• May also involve mentoring peers and/or contributing to staff performance evaluations.

⛳️ Requirements

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

• The ideal applicant will have a robust understanding of LATAM clinical trial regulations.

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

🏝️ Benefits

• Remote work option available.

• *Accommodations for applicants with disabilities can be provided upon request.