Regulatory Project Manager

Highly Competitive Salary
  1. Permanent
  2. Project Manager, Labelling & Artwork, RA Intelligence
  3. United States
North Chicago, USA
Posting date: 25 Jan 2021

Proclinical is currently recruiting for a Regulatory Project Manager with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

  • Chron files, filing and updates
  • Support Annual reports (IND and NDAs; N=70)
  • Support for preparation, follow-up for PADERS, PSURs
  • Minor labeling updates, PSN approvals, represent Regulatory on the Commercial label update team
  • Participate/manage minor supplements and amendments
  • F/U with Orange Book entries
  • Other regulatory projects

Skills and Requirements:

  • Bachelor's degree in scientific field
  • Two years of pharma experience and/or medical devices.
  • Have scientific experience
  • Needs to communicate well
  • Work in a cross-functional matrix environment
  • Feel comfortable presenting
  • Tech Savvy Systems database repository experience, need to be able to learn quick

If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.