Regulatory, Ethics & Quality
The guardians of participant protection and lawful conduct — human-research protection, regulatory submissions, quality systems, and transparency.
Who belongs here: Human research protection managers, IRB liaisons, regulatory affairs and IND specialists, QA auditors, TMF and document control, GCP trainers, CAPA managers, privacy analysts.
14 roles
Human Research Protection Program Manager
Regulatory, ethics & quality · Runs the human-research protection program: IRB submissions, consent documents, and SOPs.
IRB Liaison
Regulatory, ethics & quality · Manages IRB submissions, continuing review, amendments, and reportable events.
Regulatory Affairs Specialist
Regulatory, ethics & quality · FDA/IRB experience and botanical / dietary-supplement / drug classification familiarity.
IND / FDA Submissions Specialist
Regulatory, ethics & quality · IND preparation, eCTD familiarity, and FDA correspondence.
ClinicalTrials.gov / PRS Manager
Regulatory, ethics & quality · Trial registration and results reporting on the required timelines — central to our transparency commitments.
Trial Master File Specialist
Regulatory, ethics & quality · TMF/eTMF, essential-documents checklists, and inspection readiness.
QA Auditor
Regulatory, ethics & quality · GCP/GMP/GLP auditing as relevant, with independence disclosure.
SOP Writer
Regulatory, ethics & quality · Clear, compliant standard operating procedures and quality documentation.
GCP Trainer / Training Coordinator
Regulatory, ethics & quality · GCP/HSP training delivery, LMS experience, and training records.
CAPA Manager
Regulatory, ethics & quality · Root-cause analysis and corrective/preventive action within quality systems.
Privacy & Records Compliance Analyst
Regulatory, ethics & quality · Privacy and security practice, retention schedules, and breach-response familiarity.
Director of Regulatory Affairs
Executive & scientific leadership · Leads regulatory strategy across IND/FDA/IRB and botanical classification questions.
Director of Quality Assurance / GCP Compliance
Executive & scientific leadership · Owns the quality system: audits, SOPs, CAPA, and inspection readiness.
Regulatory Affairs Intern
Fellowship & early-career bench · Mentored internship in regulatory and compliance work with a writing sample.