Associate Director, Regulatory Submission Project Management

Location
Tarrytown, NY, United States
Posted
Sep 11, 2020
Ref
20043BR
Required Education
Bachelors Degree
Position Type
Full time
CTAs, BLAs and amendments/supplements, MAAs and variations in accordance with Regulatory regulations, guidelines, specifications (eg, FDA, EMA, ICH, etc). Direct your team in Regulatory Submission Project Management, to provide support to management.

In this role a typical day may include the following:
  • Provide oversight of therapeutic area(s) by guiding other team members who are responsible for INDs, CTAs, BLAs, sBLAs and MAAs and variations in that therapeutic area.
  • Provide mentorship to other team members and cross-functional groups to resolve issues related to timelines, submission documents or other regulatory-related matters that could impact the timeliness or quality of submissions.
  • Provide input and proposals on standardizing submission management work with the regulatory document management system to improve the functionality of the regulatory document management system
  • Guide how specific document types are led in the system with programs & partnerships involving complexities to documents being exchanged.
  • Responsible for oversights on regulatory submissions, IND safety reports, clinical site documentation updates (1572s), lot releases, promotional pieces including 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)
  • Build and lead submission plans (Table of Contents), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date. Identify potential issues that could impact the target filing date and lead discussions to reach a consensus around a solution.
  • Coordinates/Leads Regulatory Submission document writing.
  • Conduct cross-functional kickoff meetings for routine reoccurring submissions such as those for BLA annual reports, consensus meetings on critical submission documents, and IBs. These meetings can also include regulatory sub-team, ad hoc and therapeutic area discussions that involve Regulatory Liaisons and team members from partner companies
  • Provide contributions to other submission activities, such as Development Safety Update Reports (DSUR) and provides guidance on cross-reporting obligations, which include reporting of IND safety reports to multiple INDs
  • Draft cover letters for routine submissions, including those for clinical site documentation, lot releases and protocol amendments.
  • Update portfolio and management review timelines to help prepare for cross-functional and upper-management discussions, and may prepare slides for these presentations
  • Collaborate closely with Regulatory Ops, regulatory management and other functional groups to help identify or provide input on potential resource issues.
  • Provide and retrieve requested submission documents to and from partners and CROs.
  • Assist with regulatory inspection activities.
  • Identify and communicate 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.
  • Represent RSPM on enterprise system or process discussions, including those related to program management and clinical dashboards
This role might be for you if:
  • Bachelor's or Master's Degree in related field.
  • 12 -14 years of proven experience.
  • Solid understanding of applicable Regulatory Agency regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, etc)
  • eCTD experience, required.
  • Extensive project management or management experience.
  • Proven understanding of MS Project & electronic document management systems (eg, SharePoint) is strongly desired


Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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