Senior Specialist, Regulatory Operations - Remote

Overview

Care Access is seeking a skilled and experienced Senior Specialist, Regulatory Operations to join our dynamic Global Regulatory Affairs Team, part of the Global Expansion and Study Operations department. This role involves overseeing, supporting, and executing site-level regulatory operational activities for clinical trials in Canada and may also involve supporting U.S. sites as needed.

In Short

• Provide regulatory advice and execute regulatory project work.
• Support compliance activities for Canadian and U.S. clinical research sites.
• Assist in preparing for sponsor monitoring visits.
• Develop and implement regulatory strategies for site activities.
• Track essential documents and timelines.
• Coordinate REB/IRB submissions and maintain approvals.
• Ensure compliance with Good Clinical Practice (GCP) and regulatory requirements.
• Monitor changes in Canadian and U.S. regulatory policies.
• Support the development of Standard Operating Procedures (SOPs).
• Perform other duties as assigned.

Requirements

• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
• Minimum of 5 years of experience in operational regulatory affairs.
• Strong understanding of Health Canada and USA regulations.
• Excellent knowledge of site-level regulatory requirements.
• Detail-oriented with strong problem-solving abilities.
• Strong organizational and communication skills.
• Ability to work independently in a fast-paced environment.
• Experience with regulatory submissions and compliance.
• Strong computer skills, including MS Word and Excel.
• Experience with electronic Investigator Site Files systems.

Benefits

• Work in a dynamic and supportive team environment.
• Opportunity to contribute to meaningful clinical research.
• Flexible working conditions in a remote setting.
• Professional development opportunities.
• Competitive compensation package.