Director, Global Regulatory Affairs Study Start Up

Director, Global Regulatory Affairs Study Start Up (level dependent on experience) - This position is open to candidates globally

• Manages and oversees global RASSU activities.
• Provides guidance to RASSU regional leaders and fosters their collaboration and growth.
• Ensures clinical study timelines, budgets, and quality measures are met and meet / exceed accepted corporate standards.
• Embraces and implements programs that ensure quality and efficient RASSU activities.
• Attracts, develops, coaches, and retains high-performance team members, empowering them to elevate their levels of responsibility, span of control, and performance.
• Prepares and manages departmental budgets and implements cost-effective measures.
• Ensures Global Standard Operating Procedures (GSOPs) are reviewed and updated in a timely manner and abide by local guidelines and regulations.
• Oversees and administers training of all RASSU staff.
• Ensures appropriate staff review of GSOPs.
• Ensures Quality Assurance (QA) suggestions and findings are addressed in a timely manner.
• Represents CTI in developing new business, assisting with Clinical Operations presentations, reviewing bid proposals, and reviewing and facilitating out-of-scope (OOS) activities.
• Embraces departmental collaboration and harmonization on a global platform to streamline study start up and ensure continual process improvement, increase efficiencies and advances technology / software utilization.
• Drives organizational change and process harmonization within the global RASSU organization.
• Manages departmental financial metrics to meet corporate objectives.

What You'll Bring :

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit

Why CTI?

In 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 @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website ( or from our verified LinkedIn page.

Please Note

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