Senior Director - Regulatory Affairs

Location: Remote
Compensation: To Be Discussed
Staff Reviewed: Wed, May 08, 2024
This job expires in: 11 days

Job Summary

A company is looking for a Senior Director - Regulatory Affairs.

Key Responsibilities:
  • Formulate filing strategies and collaborate with Business Development
  • Review and submit regulatory applications, provide responses to agencies, and ensure compliance
  • Maintain knowledge of regulations, train staff, and facilitate communication internally and with sponsors

Qualifications:
  • Experience with Good Clinical Practice and drug development processes
  • Demonstrated knowledge of ICH guidelines and federal regulations
  • Fluency in Mandarin
  • Proficiency in computer software and databases
  • Ability to develop partnerships and present reports confidently

COMPLETE JOB DESCRIPTION

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