Associate I, Regulatory Submission Project Management

Provide support to the Regulatory Submission Project Management (RSPM) group by working on routine regulatory submissions, responsible for tracking deadlines for various regulatory obligations, and assist with submission work for major submissions such as INDs, CTAs, BLAs and supplements, MAAs and variationsIn this role a typical day may include the following:

• Schedules and manages routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces
• Supports project management work related to pre-IND or Scientific Advice submissions, INDs and CTAs, BLAs, sBLAs, MAAs and Type II variations, BLA annual reports and Investigator Brochures (IBs)
• Helps maintain submission plans (Table of Contents), timelines and responsibility matrices
• Tracks submission deliverables for routine submissions, and provides support in tracking deliverables for larger submissionsManages overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status
• Coordinates submission documents through review cycles and provides guidance to cross-functional groups on uploading submission documents to the regulatory submission document management system
• Provides support for monitoring and tracking performance of submission process for clinical site documentation (Form FDA 1572)

This role might be for you if:

You have a Bachelor's Degree with the following experience:

• Requires working knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc).
• eCTD knowledge preferred.
• Working knowledge with MS Office applications and Adobe Acrobat is required. Working knowledge of MS Project and electronic document management systems (eg, SharePoint) is desirable.