Carol Stephens Pearl Pathways Consultant Advisor

Carol Stephens, PhD

Consultant Advisor

Carol Stephens serves as a Consultant Advisor for Pearl Pathways, with a focus on regulatory affairs and compliance. Carol has 28 years of experience within the life science industry in drug development and support. Her professional competencies and experiences include:

  • Career-long expertise in regulations, guidances, and other agency directives applied to drug development
  • Lead regulatory affairs scientist for Phase I and II drugs (strategy, submissions for INDs, Canadian CTAs, European CTAs, agency interactions)
  • Integration of clinical data and regulatory strategy to achieve quality claims
  • Expertise in all phases of labeling, including PLR for USPIs, Medication Guides, Patient Package Inserts, PILs
  • Support of large and small molecules, companion diagnostics, and combination products
  • Major experience in oncology, CNS, diabetes care, and cardiovascular drugs
  • Regulatory strategies for obtaining US and EU product approvals and maintaining compliant marketed products
  • SOP development, assessment and implementation
  • Project management and alliance management
  • Medical/technical writing, including submission documents and accurate, clear consumer-oriented quality medical information

Carol completed her Ph.D. in Communications at the University of Wisconsin, Madison. She also earned M.A. and B.A. in English at the University of Illinois.