Jennifer Tucker

Global Head of Regulatory Affairs, Pathology Lab

Role
Global Head of Regulatory Affairs, Pathology Lab at 罗氏公司
Location
Tucson, AZ, US
LinkedIn followers
500 followers

About Jennifer Tucker

With over ten years of experience in the in vitro diagnostics (IVD) industry, I am a subject matter expert and a trusted advisor for diagnostic regulatory insights. I collaborate with research, development, and commercial teams to deliver solutions that support patient selection and precision medicine in oncology clinical trials.As an Associate Director at Seagen, I leverage my deep knowledge of global regulatory requirements, especially the EU IVDR, to consult on best-in-class regulatory strategies for biomarkers and CDx. I also advocate for progressive, science-based regulatory frameworks that enable innovation and access to life-saving diagnostics. I am passionate about helping talent embrace a growth mindset and achieve their full potential.

Experience

  1. Global Head of Regulatory Affairs, Pathology Lab

    罗氏公司

    Sep 2024 — Present · Tucson, AZ, US

Education

  • George Mason University

    MA, Literature (emphasis: Cultural Studies)

    2004 — 2007

  • Lipscomb University

    BS, Biology

    1999 — 2003

Skills

  • Pharmaceutical Industry
  • Sop
  • Fda
  • Quality Control
  • Quality Systems
  • Standard Operating Procedure (Sop)
  • Clinical Trial Management
  • Cgmp
  • Clinical Trials
  • Process Validation
  • Medical Devices
  • Capa
  • Regulatory Submissions
  • Regulatory Affairs
  • Regulatory Requirements
  • Validation
  • U.s. Food and Drug Administration (Fda)

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