Remote Senior Regulatory Analyst - Human Subjects

Ripple Effect; Rockville (MD); On-site; USD 68,000 - 79,000; Part time

Benefits offered by this job

Flexible work options

Job summary

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints and submissions related to human subjects research, assess regulatory significance, and help develop leadership recommendations with a focus on 45 CFR 46 compliance.

The role emphasizes attention to detail, analytical thinking, and strong written communication as you maintain records, prepare reports, and support IRB processes in a

Qualifications

• Experience in human subjects research protections and regulatory compliance.
• Proficiency with IRBs, HRPPs, and regulatory oversight.
• Ability to prepare analyses, regulatory summaries, and reports.

Responsibilities

• Be the first point of contact for communications between internal and external parties and review complaints/incidents.
• Draft correspondence, information requests, case summaries, briefing materials, and status reports for leadership.
• Track case status and milestones; ensure records management supports audit readiness.
• Contribute to compliance procedures and content development for agency reviews.
• Support leadership reporting and briefing decks for compliance teams.

Skills

Regulatory compliance

Attention to detail

Communication

Regulatory analysis

Education

Master's degree in public health/regulatory affairs

Tools

Microsoft Planner

Microsoft Project

Asana

Smartsheet

Job description

Ripple Effect is seeking a Senior Regulatory Analyst (HS/IRB) to support the Office for Human Research Protections (OHRP) within HHS. You will review complaints and submissions related to human subjects research, assess regulatory significance, and help develop leadership recommendations with a focus on 45 CFR 46 compliance.

The role emphasizes attention to detail, analytical thinking, and strong written communication as you maintain records, prepare reports, and support IRB processes in a