Associate Manager, Regulatory Submission Project Management

Location
Tarrytown, NY, United States
Posted
Sep 15, 2020
Ref
20376BR
Required Education
Bachelors Degree
Position Type
Full time
Responsible for project management of submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). May manage other team members in Regulatory Submission Project Management, and provide support and backup to management as needed.
Responsible for project management of submission deliverables such as INDs and amendments, CTAs and amendments, BLAs and amendments/supplements, MAAs and variations in accordance with applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). May lead other team members in Regulatory Submission Project Management, and provide support and backup to management as needed.
In this role a typical day may include the following:
  • Schedules and leads routine regulatory submissions, such as those for IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces and protocol amendments
  • Leads submission activities 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)
  • Builds and leads submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date. Identifies potential issues that could impact the target filing date, and leads discussions to reach a consensus around a solution.
  • Leads overall completeness of scheduled submissions and coordinates with Regulatory Operations on submission timing, and document status
  • Coordinates submission documents through review cycles and provides mentorship to cross-functional groups on uploading submission documents to the regulatory submission document management system
  • Conducts cross-functional kickoff meetings for routine reoccurring submissions such as those for BLA annual reports, consensus meetings on critical submission documents, and IBs
  • Conducts kickoff meetings for major submissions, including those for INDs, CTAs, BLAs, sBLAs and MAAs and variations
  • Provides contributions to other submission activities, such as Development Safety Update Reports (DSUR) and provides mentorship on cross-reporting obligations, which include reporting of IND safety reports to multiple INDs
  • Drafts cover letters for routine submissions, including those for clinical site documentation, lot releases and protocol amendments
  • Updates portfolio and management review timelines to help prepare for cross-functional and upper-management discussions, and may prepare slides for these presentations
  • Provides and retrieves requested submission documents to and from partners and CROs
  • Assists with regulatory inspection activities
  • Identifies and communicates regulatory system improvement needs or technical issues to management, and provides proposed solutions to areas requiring system improvements, new or revised processes, or further training or clarifying communications
This role might be for you if:

You have a Bachelor's Degree8-10 years of work experience. Requires solid understanding of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc). Requires eCTD knowledge, project management skills desired. Solid understanding with MS Office applications and Adobe Acrobat is required. Solid understanding of MS Project and electronic document management systems (eg, SharePoint) is desirable.

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