Senior Specialist, Regulatory Operations

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Specialist, Regulatory Operations based in Canada.

This role offers the opportunity to support impactful clinical research initiatives by ensuring regulatory excellence throughout the study lifecycle. You will manage critical regulatory operations for clinical trial sites, helping teams maintain compliance with evolving requirements and industry standards. The position requires strong knowledge of U.S. regulatory frameworks, clinical research processes, and site-level operational activities. You will collaborate with clinical operations, quality, sponsors, and research teams to support successful study execution. Your expertise will help accelerate access to innovative healthcare solutions while maintaining the highest standards of regulatory compliance. This is an ideal opportunity for a detail-oriented regulatory professional who thrives in a fast-paced, mission-driven environment.

Accountabilities:: As a Senior Specialist, Regulatory Operations, you will oversee and execute regulatory activities supporting clinical research sites across the United States while ensuring compliance with applicable regulations, guidelines, and internal processes. You will provide strategic guidance, maintain regulatory documentation, and collaborate with cross-functional teams to support successful study delivery. Key responsibilities include:

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.

Coordinate preparation, review, submission, and tracking of IRB materials, including protocols, informed consent forms, amendments, and supporting documentation.

Manage essential regulatory records, ensuring Investigator Site Files are complete, accurate, inspection-ready, and compliant with regulatory requirements.

Support site teams through key milestones, including site evaluation visits, initiation visits, consent readiness, and study closeout activities.

Prepare and support sponsor monitoring visits, audits, and regulatory inspections by ensuring documentation readiness and timely follow-up.

Monitor regulatory updates and provide guidance on changing requirements, industry practices, and country-specific considerations.

Partner with Clinical Operations, Quality, and other stakeholders to identify process improvements and strengthen regulatory workflows.

Contribute to the creation and maintenance of SOPs, work instructions, templates, and departmental processes.

Track study milestones, regulatory timelines, performance indicators, safety reports, deviations, and amendments to support operational success.

Provide regulatory guidance and training support to site staff and internal teams when needed.

Requirements: The ideal candidate is an experienced regulatory operations professional with strong clinical research knowledge and the ability to manage complex regulatory activities independently. You should be detail-oriented, collaborative, and comfortable working in a dynamic environment where accuracy and compliance are essential. Key qualifications include:

Bachelor’s degree in a scientific, healthcare-related, or equivalent field; advanced degree preferred.

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.

Experience supporting clinical trial site operations throughout the full study lifecycle.

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.

Client-focused mindset with strong attention to detail, adaptability, and commitment to quality.

Benefits: The company offers a competitive compensation package and benefits designed to support employees’ health, wellbeing, and professional growth. Benefits include:

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.

401(k) retirement plan with company match.

Paid time off (PTO) and company-paid holidays.

Opportunity to contribute to meaningful healthcare and clinical research initiatives.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1