CRO Regulatory Specialist; Boston, MA

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

• Bachelor's degree (required) in Life Sciences, Pharmacy, Regulatory Affairs, or related field. Master’s degree preferred.
• Minimum 5 years in clinical research with 3+ years in regulatory affairs at a CRO or sponsor.
• RAC (Regulatory Affairs Certification) preferred. Current GCP training certification required.
• Deep understanding of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312/812), ICH GCP guidelines (E6(R3)), and global regulatory requirements.

• 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

• 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.
• 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.

• Support data integrity initiatives following ALCOA+ principles.
• Facilitate audit trail review and documentation.
• Collaborate on the validation of computerized systems (CTMS, EDC).
• Create regulatory guidance for emerging technologies and data sources.

• 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.