Job Description
CRO Regulatory Specialist Job Description The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors and sites in meeting FDA, ICH, and GCP requirements. This role serves as the liaison between clinical operations, quality assurance, and regulatory authorities.
Reports to: Evidence Generation Leadership
Qualifications & Education Education :
Bachelor's degree (required) in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Master's degree preferred.
Experience: Minimum 5 years in clinical research with 3+ years in regulatory affairs at a CRO or sponsor.
Certifications: RAC (Regulatory Affairs Certification) preferred. Current GCP training certification required. Regulatory Knowledge: Deep understanding of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312/812), ICH GCP guidelines (E6(R3)), and global regulatory requirements.
Key Skills & Competencies Technical Expertise Regulatory Submissions ICH/GCP Guidelines SOP Development Compliance Assessments
Problem Solving Risk Management Quality Management Systems Professional Attributes Critical Thinking Attention to Detail Cross-functional Collaboration Written/Verbal Communication Time Management A key role ensuring regulatory compliance throughout the clinical trial lifecycle, maintaining GCP standards, and supporting inspection readiness.
Position Overview Core Responsibilities GCP Compliance & Quality Oversight Develop and maintain quality management systems that ensure protocol adherence
Conduct GCP compliance assessments and site readiness evaluations
Lead the implementation of risk-based monitoring strategies
Coordinate CAPA development and implementation for compliance issues
Regulatory Documentation & Submissions Prepare and review regulatory submission documents (IND/IDE, amendments)
Ensure completeness and compliance of essential documents
Manage regulatory document workflows and tracking systems
Support eTMF management for inspection readiness
Study Oversight & Data Management Support data integrity initiatives following ALCOA+ principles
Facilitate audit trail review and documentation
Collaborate on validation of computerized systems (CTMS, EDC)
Create regulatory guidance for emerging technologies and data sources
Performance Expectations Maintain 100% compliance with regulatory requirements across assigned studies
Successfully support regulatory inspections with minimal or no critical findings
Develop and maintain effective relationships with sponsors, sites, and regulatory authorities
Contribute to continuous improvement of regulatory processes and documentation systems
This role is critical to ensuring the CRO maintains its reputation for regulatory excellence and contributes directly to the successful approval of sponsors' drug development programs.
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