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Associate I, Regulatory Submission Project Management

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, NY, United States
Start date
Jan 16, 2021

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Discipline
Clinical, Clinical Project Management, Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work
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Job Details

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
 Tarrytown
New York
10591
United States
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