Meagan Gerbig

Meagan Gerbig

Regulatory Project Manager

Meagan comes to Biologics Consulting with over 7 years of experience working for pharmaceutical companies. Most recently, she worked for Regeneron Pharmaceuticals as a Regulatory Systems Specialist. In that role, she supported various regulatory computer systems, providing training and technical support to users company-wide. Prior to Regeneron, Meagan worked in Regulatory Operations at Array BioPharma. At Array, Meagan was responsible for all document publishing, hyperlinking, bookmarking, and submission compilation.

As a Project Manager/E-publishing Associate at Biologics Consulting, Meagan will utilize her technical and regulatory expertise to assist clients in the following:

  • Providing Project Management and Electronic Publishing submission support, with respect to original INDs, BLAs, ANDAs, and Master Files in both legacy and eCTD format and maintenance of those submissions
  • Perform quality control review of published submissions
  • Create and finalize SOPs
  • Provide assistance with authoring, managing, and overseeing proposal development for multi-disciplinary projects
  • Miscellaneous administrative duties as necessary

Education

BS, Biomolecular Science, Clarkson University, Potsdam, NY (2005)

Continuing Education:

Drug Information Association Annual Conference (2008, 2013)

ShareFEST - The SharePoint Conference for Life Sciences (2012)

Leveraging Global eCTD Efficiencies (2010)
ExL Pharma

Preparing Compliant eCTD Submissions (2007)
Regulatory Affairs Professionals Society

Regulatory Affairs Professional Society Annual Conference (2007)

Preparation of FDA Submissions and Communicating with the FDA (2007)
Center for Professional Innovation & Education