Regulatory Affairs Manager

1 week ago


Pleasanton, Kansas, United States Crystal Pharmatech Full time
Job Description

Candidate is expected to establish and administer quality systems supporting compliant nonclinical laboratory study GLP and or phases thereof and testing activities producing primary or secondary endpoints of clinical studies GCLP. The individual should assure that facilities, equipment, personnel, methods, practices, records, and controls are in conformance of regulations.

Main Responsibilities:
  • GLP Compliance: Establish company compliance of GLP and GCLP and GCPs for FDA and applicable international regulations.
  • QA Standard Operating Procedures: Establish and administer QA Standard Operating Procedures (SOPs), QA Files, and QA Audit Log.
Requirements:
  • Bachelor's degree in biological or physical sciences required; advanced degrees preferred.
  • 10+ years of relevant Regulatory Affairs experience in the Bioanalytical CRO space and/or biotechnology/pharmaceutical industry.
  • Able to provide regulatory leadership and guidance on cross-functional teams.
Estimated Salary: $140,000 - $200,000 per year

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