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Regulatory Affairs Manager

  • Newport Beach, CA
  • Direct Hire
  • Job ID: CA44-2700150

Description

The key responsibilities for the Regulatory Affairs Manager are:

  • Maintain compliance for a vast and diverse product catalog and multiple business practices.
  • Drive policies and procedures adherence throughout the organization in relation to regulatory standards.
  • With the support of external consultants, work to ensure facilities are properly licensed to distribute pharmaceuticals at the federal and state level
  • Coordinate with software providers and facility level designated representatives to ensure compliance with serialization requirements and the DSCSA (Drug Supply Chain Security Act), generally.
  • Support securing additional facility approvals and registrations for pharmaceuticals and repackaging as necessary.

The successful Regulatory Affairs Manager will have

  • Bachelors Degree
  • 5+ years of experience
  • Experience with U.S. and international regulatory
  • Knowledge of existing and proposed laws and regulations that may impact business practices
  • Familiarity with researching legislation and regulatory guidance
 
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