Regulatory Affairs Manager (level dependent on experience)

Job Summary: Independently manages essential regulatory effort and documentation for multiple studies or projects in different countries and assists with providing ongoing guidance and direction to Sponsors and other CTI departments. Provide Line management for Regulatory Specialists and coordinators group.

**Please note that this position will be office based at our Covington, KY office location.**

What You'll Do:

• Oversee and guide regulatory documents processes and regulatory specific timelines assessments for each study; monitors against study progress and ensures study activity is in compliance with relevant processes; suggests and implements alternative solutions for regulatory issues identified and takes corrective action where necessary
• Assess regulatory resources needs and establishes appropriated teams for each study in conjunction with specific study goals, monitors ongoing resources needs against performance
• Ensure the timeline milestones and appropriate study maintenance at all stages of study conduct are met
• Organize support in case of critical timelines in specific projects and organizes representation for Reg. Specialists in case of vacation or sickness
• Provide input for new business development (NBD) proposals and assist or participates in Bid Defense and Capability Meetings
• Provide appropriate education and training to CTI staff to maintain up-to-date understanding of International Council for Harmonization (ICH)/Good Clinical Practice (GCP) and other regulatory guidelines
• Keep up to date in and review national and international regulatory laws and guidelines regarding regulatory requirements
• Attend internal and external study meetings and provide regulatory status reports
• Invite and lead internal Regulatory team meetings
• Check the status of ongoing studies regarding SSU and eTMF and take care that these are up to date
• Organize the check of the eTMF and SSU regarding correct naming and filing as well as completes of regulatory documents
• QC and QA of various study related Regulatory documents and reports
• Develop or update relevant SOPs as needs are identified and monitor for process updates and improvements to current SOPs
• Train and mentor less experienced Regulatory staff and other CTI functional staff members
• Provide guidance and mentorship to direct reports while overseeing and managing their work product
• Provide Line management for Regulatory Specialists and coordinators group
• Depending on the resources provide Regulatory Specialist Services

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

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 support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
• Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
• Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

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