Job Summary: The Regulatory Affairs Study Start-Up Manager provides line management, coaching, and professional development for Regulatory Specialists and Regulatory Coordinators while overseeing the delivery and quality of regulatory and study start-up activities across multiple studies and countries. This role provides regional oversight, supports central and local submission strategies, manages regulatory timelines and risks, and partners with sponsors and cross-functional teams to ensure compliant, timely, and inspection-ready study execution.
This position will be office based at either our headquarters located in Covington, KY or our office in Raleigh, NC.What You'll Do:- Provide day-to-day line management for assigned direct reports, including objective setting, workload oversight, regular one-to-one meetings, performance reviews, and timely performance feedback
- Coach and mentor team members to strengthen technical and leadership capabilities, support professional development and career progression, and promote engagement, accountability, and succession readiness
- Oversee regulatory document processes and study-specific regulatory timelines; monitor progress and compliance with applicable procedures, identify emerging issues, and implement corrective or alternative solutions as needed
- Assess study-specific regulatory resource needs, establish appropriate teams aligned with study goals, and monitor staffing requirements and performance throughout study delivery
- Ensure regulatory milestones are achieved and study maintenance activities are completed appropriately throughout all stages of study conduct
- Coordinate additional support for studies with critical timelines and ensure appropriate coverage during planned or unexpected staff absences
- Contribute regulatory expertise to new business development proposals and participate in bid defenses and capability meetings
- Provide education and training to support current understanding of International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP), and other applicable regulatory requirements
- Maintain current knowledge of national and international regulatory requirements, guidance, and industry practices, and assess their impact on study-start-up activities
- Represent Regulatory Affairs in internal and external study meetings and communicate clear, timely status updates, risks, and recommended actions
- Plan and lead internal regulatory team meetings to align priorities, address risks, and drive timely decision-making
- Monitor study start-up (SSU) and electronic trial master file (eTMF) status across active studies and ensure records remain current, complete, and inspection-ready
- Oversee quality reviews of SSU and eTMF content to confirm accurate naming, filing, and completeness of regulatory documentation
- Perform or oversee quality control (QC) and quality assurance (QA) reviews of study-related regulatory documents and reports
- Develop and update standard operating procedures (SOPs) as needs are identified, and lead continuous improvement of regulatory processes and supporting procedures
- Provide hands-on Regulatory Specialist support when required by business priorities and available resources
What You'll Bring:- Bachelor's Degree in allied health field such as nursing, pharmacy or health science or the equivalent relevant experience
- At least 10 years pharmaceutical or CRO Clinical Regulatory experience
- Strong working knowledge and understanding EU regulations, Good Clinical Practice (GCP) International Council for Harmonization (ICH) regulation and guidelines
- Demonstrated knowledge of and experience with central and local regulatory and ethics submission processes in the United States and Canada; experience across Latin America is also preferred
- Experience providing regional oversight of regulatory and study start-up activities, including coordination across countries, management of submission strategies and timelines, identification and escalation of risks, and alignment with sponsors and cross-functional stakeholders
Important NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note- We will never communicate with you via Microsoft Teams or text message
- We will never ask for your bank account information at any point during the recruitment process
