Kim Parker

About Kim Parker

Senior Specialist, Regulatory AffairsVersatile and accomplished Regulatory Affairs professional with expertise in Biopharma, CMC, and Quality. Adept at steering the development and submission of critical documents to ensure EU and USFDA compliance.Specializing in single-use systems (SUS) for biopharmaceutical manufacturing, I work closely with cross-functional teams to support sterilization validation, extractables & leachables assessments, and regulatory strategy. Experienced in navigating complex global standards, including USP /, ISO and emerging regulations impacting SUS, I bridge technical requirements with practical, customer-focused solutions.Passionate about driving regulatory excellence and enabling safe, compliant, and innovative bioprocessing technologies.#RegulatoryAffairs #SingleUseSystems #Biopharma #FDACompliance #EU_MDR #CMC #QualityAssurance #RegulatoryExcellence #SterilizationValidation #ExtractablesAndLeachables

Experience

1. Senior Regulatory Affairs Specialist

   Meissner

   Feb 2024 — Present · CA, US

Education

• Northeastern University

  Master of Science - MS, Regulatory Affairs

  2017 — 2019

• University of Colorado at Colorado Springs

  Bachelor of Arts, Biology; Biochemistry

  1999 — 2003

Skills

• Medicine
• Digital Imaging
• Powerpoint
• Microsoft Excel
• Glp
• Laboratory Research
• Healthcare
• Research
• Biochemistry
• Biotechnology
• Medical Terminology
• Microbiology
• Leadership
• Training
• Cell Culture
• Science
• Aseptic Technique
• Statistics
• Microsoft Office
• Microscopy
• Teaching
• Teamwork
• Customer Service
• Histology
• Management
• Medical Devices
• Gel Electrophoresis
• Biology
• Molecular Biology
• Laboratory
• Technical Writing
• Elisa
• Diagnostics
• Protocol
• Sterilization
• Lifesciences
• Inventory Management
• Pcr
• Critical Thinking
• Laboratory Techniques