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
