Regulatory Affairs Lead

Remote | Full-Time

About the Role

We are seeking an experienced Regulatory Affairs Lead to support clinical trial execution across a multi-site clinical research network. Working closely with the Director of Regulatory Affairs and Quality Assurance, this role will provide leadership and oversight of study-level regulatory activities from feasibility and study start-up through continuing review and study close-out.

The Regulatory Affairs Lead will manage regulatory requirements across multiple clinical trials and projects, serve as a key point of contact for IRBs, Sponsors, CROs, investigators, and internal teams, and ensure studies remain compliant with applicable protocols, SOPs, ICH/GCP guidelines, and regulatory requirements.

This is an excellent opportunity for a regulatory professional who is highly organized, proactive, detail-oriented, and comfortable managing multiple priorities in a fast-paced, multi-site research environment.

What You'll Do

Lead Study-Level Regulatory Activities

• Proactively manage regulatory activities across assigned clinical trials from feasibility through study close-out.
• Maintain accurate study trackers and communicate study-level regulatory updates and priorities to internal teams.
• Establish and maintain effective regulatory timelines and operational plans for each assigned study.
• Work collaboratively with internal teams to prioritize activities in accordance with study plans, SOPs, ICH/GCP guidelines, and applicable regulatory requirements.
• Identify potential study risks and escalate regulatory or operational concerns to the Director of Regulatory Affairs and Quality Assurance as appropriate.

Support Feasibility & Site Selection

• Coordinate and support Pre-Selection Visits (PSVs) for assigned studies.
• Complete Sponsor/CRO source document agreements, feasibility questionnaires, and other required documentation.
• Attend PSVs and ensure outstanding regulatory documents and follow-up items are completed and submitted promptly.
• Partner with Sponsors, CROs, investigators, and site teams throughout the feasibility process.

Lead Study Start-Up

• Lead regulatory activities associated with study activation and start-up.
• Prepare and maintain essential regulatory documents required for site activation.
• Review informed consent documents for accuracy and completeness.
• Prepare and submit initial site IRB submissions.
• Coordinate and schedule Site Initiation Visits (SIVs).
• Create and maintain study and Investigator Site Files (ISFs) within CRIO or similar clinical research platforms.
• Develop and organize study source documents and other regulatory materials required for study activation.
• Track outstanding start-up requirements and proactively drive items toward completion.

Manage IRB & Regulatory Submissions

• Prepare and submit regulatory documents to the IRB throughout the study lifecycle, including:
  • Initial study submissions
  • Continuing reviews
  • Site closure submissions
  • Unanticipated problems
  • Protocol deviations
  • Other required study amendments and regulatory submissions
• Serve as the primary regulatory point of contact with the IRB for assigned studies.
• Track IRB submissions, approvals, and required follow-up actions to ensure timely completion.
• Communicate IRB decisions and regulatory requirements to investigators and site teams.

Manage Protocol Amendments & Informed Consent Updates

• Notify study sites of approved protocol amendments and communicate key changes that require implementation.
• Provide sites with protocol amendment checklists and support appropriate implementation.
• Communicate informed consent approval updates to study sites, including the rationale for revisions when applicable.
• Provide consent implementation checklists and ensure required updates are appropriately documented.

Maintain Regulatory Files & Audit Readiness

• Maintain assigned Investigator Site Files and study-level regulatory documentation.
• Prepare and route documents for investigator and study staff review and signature.
• Ensure regulatory documents are filed accurately and in accordance with company SOPs.
• Prepare regulatory files and documentation for monitor visits, quality visits, and audits.
• Ensure documentation remains complete, current, and inspection-ready throughout the study lifecycle.

Cross-Functional Study Oversight

• Participate in weekly Study Start-Up meetings, biweekly Quality Meetings, SIVs, Sponsor/CRO meetings, and other study meetings as assigned.
• Track and follow up on outstanding regulatory action items.
• Provide regular updates to leadership regarding study timelines, enrollment plans, quality standards, regulatory progress, and potential risks.
• Collaborate with study operations, site leadership, investigators, quality, and other internal teams to ensure successful study execution.
• Manage multiple studies and competing priorities while maintaining a high level of accuracy and responsiveness.

What You'll Bring

• Bachelor's degree in Business, Health Science, or a related field preferred, or equivalent combination of education and experience.
• 4–6 years of hands-on clinical research experience, with a strong understanding of clinical study operations and protocols.
• Demonstrated experience in clinical research regulatory affairs, preferably with experience supporting studies from feasibility and start-up through close-out.
• Strong understanding of regulatory requirements and clinical research guidelines.
• Experience with IRB submissions and ongoing IRB management.
• Experience with essential regulatory documents and Investigator Site Files (ISFs).
• Familiarity with clinical research systems such as CRIO or similar platforms.
• Knowledge of and adherence to Good Clinical Practice (GCP), IATA, and FDA regulations.
• Strong understanding of study start-up processes, protocol amendments, informed consent updates, and regulatory documentation.
• Excellent interpersonal and communication skills, with the ability to work effectively with Sponsors, CROs, investigators, IRBs, and internal teams.
• Highly organized with exceptional attention to detail.
• Able to manage multiple studies, deadlines, and competing priorities in a high-volume environment.
• Proactive problem solver who can identify risks, drive action items to completion, and escalate issues appropriately.
• Flexible and adaptable in a dynamic clinical research environment.

Why Join Us?

As a Regulatory Affairs Lead, you'll play a critical role in ensuring clinical trials move efficiently from feasibility through activation and ongoing execution while maintaining the highest standards of regulatory and quality compliance.

You'll have the opportunity to work across a multi-site clinical research network, collaborate with investigators, Sponsors, CROs, and research operations teams, and take meaningful ownership of regulatory activities across multiple studies.

If you're an experienced regulatory professional who enjoys owning projects, solving problems, and helping clinical trials move forward, we'd love to hear from you.