Manager Regulatory Submission Project Management

Tarrytown, New York
Nov 06, 2021
Required Education
Masters Degree/MBA
Position Type
Full time

Responsible for project management of European and U.S. submission deliverables such as CTAs and INDs and related amendments, MAAs and BLAs and related variations and supplements, in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (e.g., EMA, MHRA, FDA and ICH). Responsibilities include but are not limited to:

  • Schedules and manages routine submissions, such as those for CTA and related amendments, IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces and protocol amendments

  • Provides contributions to other submission activities, such as Development Safety Update Reports (DSUR), and tracks CTA submissions performed by CROs, including those for Investigator Brochures (IB) to track Reference Safety Information (RSI) updates

  • Creates and manages submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date

  • Manages overall completeness of scheduled submissions and coordinates with Regulatory Publishing 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

  • Facilitates or conducts kickoff and working discussions for major submissions, including those forĀ  CTAs, INDs, MAAs and variations, and BLAs and sBLAs

  • Prepares and presents timelines and timeline scenarios for cross-functional and senior management discussions

  • Provides and retrieves requested submission documents to and from partners and CROs

  • Assists with regulatory inspection activities

  • Identifies and communicates regulatory system enhancement needs or technical issues to management, as needed

  • Requires strong knowledge of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)

  • Requires eCTD knowledge

  • Project management skills desired

  • 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.