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'sdegree 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. #J-18808-Ljbffr Cedent Consulting
...across different fields and industries.??? Are you ready to help us make the future?? ?? ABOUT THE ROLE: As a Materials Engineering/Materials Science Intern here at Honeywell, you will have the opportunity to gain hands-on experience in the field of materials...
At Houston Methodist, the Audiology Assistant position is responsible for providing highly competent knowledge in hearing management and care. Independently manages patient needs related to basic hearing aid care; responsible for hearing aid supplies; and maintains incoming...
Are you an experienced caregiver? Do you enjoy making a difference in someones life? Our goal at Griswold Care Pairing of Chester and Lancaster... ...Care Pairing of Chester and Lancaster County, seniors can live in the home that they love while receiving the assistance they...
...Job Description Job Description Were hiring Entry-Level Event Assistants to join our fast-growing team and help deliver exciting... ...activations . No experience? No problem! We provide paid training, hands-on experience, and a clear path to growth in event coordination...