Heidi Unger

Heidi Unger serves as a Senior Analyst, RA/QA for Pearl Pathways. She coordinates regulatory filings, leads cross-functional teams, advises sponsors regarding regulatory submission requirements, writes and reviews regulatory documents and SOPs, tracks collaborative teamwork and project documentation, and serves as project manager.

Previously, she was responsible for leading cross-functional teams through the eCTD regulatory filing process, managing Pearl’s submissions schedule, tracking and organizing files through multiple versions, and putting the finishing touches on submission files so that they meet regulatory agency requirements. She uses eCTD software to assemble regulatory filings based on the eCTD table of contents, adds the appropriate metadata and hyperlinks, and compiles submissions for electronic delivery to regulatory agencies. Heidi is experienced with publishing INDs, NDA and ANDA filings, annual reports, amendments, safety reports, and meeting requests. She has also submitted to FDA and EMA. 

Heidi is a versatile professional with over eighteen years of writing and editing experience leading book publishing projects while managing multiple assignments, timelines, and budgets. This experience enables Heidi to leverage strong project management skills to prepare submissions, understand client needs and agency specifications, arrange and edit complex documents, and accurately document procedures. She also serves as a nonscientific IRB board member for Pearl IRB. Heidi earned a BA in English and Journalism from Franklin College of Indiana.