Senior Specialist, Regulatory Operations

Role Overview

This opportunity offers a senior regulatory operations specialist position based in the United States, partnering with clinical research teams to ensure regulatory compliance throughout clinical trials. The role focuses on managing critical regulatory functions at clinical trial sites, facilitating compliance with evolving U.S. regulations and industry standards, and collaborating cross-functionally to support study success.

Key Responsibilities

• Lead regulatory operational activities supporting clinical trials under U.S. regulatory frameworks, including FDA guidelines, OHRP standards, and ICH GCP principles.
• Manage regulatory tasks at the site level such as study startup, ongoing maintenance, and closeout processes.
• Devise and implement regulatory strategies to streamline site operations and clinical trial execution.
• Oversee preparation, review, submission, and tracking of IRB materials, including protocols, consent forms, amendments, and supporting documents.
• Maintain comprehensive, accurate, and inspection-ready Investigator Site Files ensuring compliance with regulatory requirements.
• Support site teams during key milestones such as site evaluation, initiation, consent readiness, and study closure.
• Prepare and assist with monitoring visits, audits, and regulatory inspections ensuring readiness and timely follow-up.
• Monitor regulatory updates to provide guidance on changes in requirements, industry practices, and country-specific rules.
• Collaborate with Clinical Operations, Quality, and other teams to identify process improvements and enhance regulatory workflows.
• Contribute to development and upkeep of SOPs, work instructions, templates, and departmental processes.
• Track study progress, regulatory timelines, performance metrics, safety reports, deviations, and amendments to support operational excellence.
• Deliver regulatory guidance and provide training support to site staff and internal teams as needed.

Candidate Requirements

• Bachelor's degree in a scientific or healthcare-related field required; an advanced degree is advantageous.
• At least 4 years of experience in regulatory operations within clinical research sites, CROs, pharmaceutical firms, or similar environments.
• Deep understanding of U.S. regulatory requirements, FDA regulations, and ICH Good Clinical Practice guidelines.
• Proven experience managing IRB submissions, regulatory documentation, and maintaining ongoing compliance.
• Familiarity with clinical trial site operations across the full study lifecycle.
• Experience with electronic Investigator Site File (eISF) platforms such as Florence or CRIO.
• Excellent organizational skills with ability to juggle multiple priorities and meet deadlines under fast-paced conditions.
• Strong communication skills for effective collaboration with internal teams, sponsors, and external stakeholders.
• Proactive problem-solving skills and ability to independently overcome regulatory challenges.
• Proficiency in Microsoft Office (Word, Excel) and clinical trial database systems.
• Ability to work autonomously while collaborating well within diverse teams.
• Attention to detail, adaptability, client-focused mindset, and commitment to quality.

Benefits and Working Conditions

• Competitive yearly salary approximately between 90000 and 100000 USD.
• Fully remote working setup available across the United States or Canada.
• Flexible working arrangements with minimal travel required (typically less than 10%).
• Comprehensive medical, dental, and vision insurance options with employer-funded plans.
• Access to Health Savings Account (HSA) and Flexible Spending Account (FSA) with employer contributions towards HSA.
• Company-paid short-term and long-term disability coverage.
• 401(k) retirement plan with company matching contributions.
• Paid time off and company-observed holidays.
• Meaningful involvement in advancing healthcare and clinical research endeavors.

Additional Information

This role is managed by a partner company that handles application reviews and subsequent selection steps. A data privacy note clarifies personal data handling under GDPR and other protections, and the use of AI tools assists recruitment but does not replace human decision making.