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

What You'll Do:

• 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.
• Ensure 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:

• At least 15 years of CRO or relevant experience, including previous experience, managing large global teams and multinational complex aspects of global Regulatory Affairs and study start up activities
• MS or PhD degree in health-related area or equivalent experience as determined by CTI Management and Human Resources

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 www.ctifacts.com

Why CTI?

• Advance Your Career – We invest in your professional growth. Our structured mentoring program, leadership development courses, and dedicated training department provide the support you need to excel. We also encourage ongoing education to help you achieve your professional goals.
• Join an Award-Winning Team – Join a global team spanning 60 countries, recognized for its award-winning culture that prioritizes people. We support your work-life balance with hybrid work opportunities. Through our CTI Cares program, you’ll have opportunities to give back to your community and the world.  
• Make a Lasting Impact – At CTI, your work directly contributes to advancing medicine. You’ll play a vital role in developing life-changing treatments for patients with chronic and critical illnesses. Together, we move medicine forward, making a difference for those who need it most.

Important Note
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 (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