Senior Specialist, Regulatory Operations

Accountabilities

• Lead and execute regulatory operational activities for assigned clinical trials, ensuring compliance with U.S. regulatory requirements, FDA guidelines, OHRP standards, and ICH GCP principles.
• Support site-level regulatory activities, including study start-up, ongoing maintenance, and close-out processes.
• Develop and implement regulatory strategies that enable efficient site operations and successful trial execution.
• Collaborate with cross-functional teams to support successful study delivery.

Requirements

• The ideal candidate is an experienced regulatory operations professional with strong clinical research knowledge and the ability to manage complex regulatory activities independently.
• Minimum of 4 years of experience in regulatory operations, preferably within clinical research sites, CROs, pharmaceutical companies, or related environments.
• Strong understanding of U.S. regulatory requirements, FDA regulations, and ICH Good Clinical Practice (GCP) guidelines.
• Proven experience managing IRB submissions, regulatory documentation, and ongoing compliance activities.
• Familiarity with electronic Investigator Site File (eISF) systems such as Florence, CRIO, or similar platforms.
• Strong organizational skills with the ability to prioritize multiple tasks and meet deadlines in a fast-paced environment.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with internal teams, sponsors, and external stakeholders.
• Strong problem-solving abilities with a proactive approach to identifying and resolving regulatory challenges.
• Proficiency with Microsoft Office tools, including Word and Excel, and experience using clinical trial databases.
• Ability to work independently while maintaining strong collaboration across diverse teams.
• A client-focused mindset with strong attention to detail, adaptability, and commitment to quality.

Benefits

• Competitive annual salary range of approximately $90,000 - $100,000 USD.
• Fully remote work environment within the United States or Canada.
• Flexible work arrangements with limited travel requirements (less than 10%).
• Medical, dental, and vision insurance options with employer-paid plans.
• Health Savings Account (HSA) and Flexible Spending Account (FSA) options.
• Employer contributions toward HSA plans.
• Company-paid short-term and long-term disability insurance.
• Paid time off (PTO) and company-paid holidays.
• Opportunity to contribute to meaningful healthcare and clinical research initiatives.