Regulatory Affairs Manager

Job Description:

• Pay: 63.00-65.77/hr.
• Length of Assignment: Budgeted through 2025 with potential for extension. 
• Will work as a liaison between stakeholders and vendors to derive information for the creation and editing of ECTD submissions, acting as a quality control person on ECTD components, they will check the submission(s) for necessary bookmarks and relevant regulatory information as well as coordinate publishing with the vendor. 
• Responsible for finding errors within the documents and follow up on corrections that need to be made prior to submission for publishing.
• 5 plus years in Regulatory Operations. Must know regulations and have insight on what to look for in the ECTD documents. Must be knowledgeable with US region regulations about ECTD submission, must be able to meet deadlines and oversee deliverables on document submissions. Also, have the insight to find errors and follow up on correction of errors within the document.
• Must have at least 3 years of Submission Delivery Support experience, must have US and European regulatory knowledge. Experience with managing publishing vendors is a plus.
• Performs eCTD submission management across product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Ops. Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. 
• Oversee outsourced publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products.
• Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle.