Job Title: Director, Global Regulatory Affairs Study Start Up
This is a level-dependent position open to candidates globally.
* Manage and oversee global RASSU activities.
* Provide guidance to RASSU regional leaders and foster their collaboration and growth.
* Ensure clinical study timelines, budgets, and quality measures are met and meet/exceed accepted corporate standards.
* Embrace and implement programs that ensure quality and efficient RASSU activities.
* Attract, develop, coach, and retain high-performance team members, empowering them to elevate their levels of responsibility, span of control, and performance.
* Prepare and manage departmental budgets and implement cost-effective measures.
* Ensure Global Standard Operating Procedures (GSOPs) are reviewed and updated in a timely manner and abide by local guidelines and regulations.
* Oversee and administer training of all RASSU staff.
* Ensure appropriate staff review of GSOPs.
* Ensure Quality Assurance (QA) suggestions and findings are addressed in a timely manner.
* Represent CTI in developing new business, assisting with Clinical Operations presentations, reviewing bid proposals, and reviewing and facilitating out-of-scope (OOS) activities.
* Embrace departmental collaboration and harmonization on a global platform to streamline study start up and ensure continual process improvement, increase efficiencies, and advance technology/software utilization.
* Drive organizational change and process harmonization within the global RASSU organization.
* Manage departmental financial metrics to meet corporate objectives.
Requirements:
* 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.
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 hiring scams, if selected for further consideration, a member of our team will contact you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you apply for jobs directly on our website or from our verified LinkedIn page. 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.