Regulatory Officer

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

📋 Description

• Develop clinical trial submission documents for Regulatory and Ethics Authorities, with an emphasis on submissions for Canadian and US regulations, including applications for Import and Export licenses.

• Liaise with regulatory authorities, ethics committees, project teams, and vendors regarding regulatory matters.

• Assess translations of key documents related to clinical trial submissions.

• Monitor the flow of regulatory project documentation.

• Evaluate documents to authorize the release of Investigational Product (IP) to sites.

• Oversee safety reporting to authorities.

• Provide regulatory training to project teams.

• Support feasibility studies and respond to business development inquiries.

⛳️ Requirements

• College/University degree or an equivalent combination of education, training, and experience.

• Previous experience with clinical trial submissions in North America.

• Full working proficiency in English and French, with native proficiency in French being essential; Spanish proficiency is a plus.

• Competency in MS Office applications.

• Strong attention to detail.

• Ability to learn, organize, and collaborate effectively in a dynamic team environment.

• Excellent communication, collaboration, and problem-solving skills.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.