Regulatory Operations Specialist II

Job Purpose/ Summary: Responsible for publishing submission documents to FDA specifications in eCTD format, building submissions in the eCTD software, completing submission to regulatory authorities, quality checking documents authored by CTI or others, and other tasks as required. Under the direction of the Manager / Senior Manager / Director, Regulatory & Scientific Affairs.

What You'll Do:

• Electronic document publishing of all modules with a competency component in the component locations within the electronic common technical document (eCTD) outline structure
• Ensure documents are published to applicable regulatory authority standards
• Ensure documents are eCTD compliant in style and conventions
• Manage receipt of submission components and workflow to ensure a high-quality final submission
• Ensure issues are identified at an early date and actively contribute to issue resolution before filing dates are impacted
• Quality check documents based on the type of QC (format, style, consistency, reference, numbers) in accordance with the CTI Style Guide
• Ensure adherence to internal and external standards including SOPs, Guidance Documents, and Policies
• Coordinate publishing and QC tasks across projects
• Support various internal functional groups to ensure compliant use of eCTD Authoring guidelines, style, and conventions
• Ensure tracking and archiving of regulatory filings, correspondence, and related information for various regulatory applications
• Perform U.S. regulatory research tasks as related to Regulatory Technology and Operations
• Attend internal team meetings to collect and organize potential upcoming publishing, submission, and QC tasks
• Contribute to brainstorming and troubleshooting of technical issues that impact validation requirements for submission dispatch; complete submissions to the FDA
• Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems, and procedures

What You'll Bring:

• Bachelor’s degree in fields such as allied health, nursing, pharmacy or health/natural science or an equivalent combination of education and relevant work experience
• At least 2 years of experience quality checking and authoring documents and/or compiling, publishing, and coordinating electronic submissions
• Understanding eCTD structure of all modules with a competency in the component locations within the eCTD outline structure preferred
• eCTD submission building, validating, and submission experience preferred
• General regulatory submission management experience preferred
• Working knowledge of StartingPoint templates, eCTD software, Adobe Acrobat Professional, Endnote, and Authoring templates preferred

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