Remote Regulatory Affairs Manager

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Wed, Jan 19, 2022
Job Summary

A biotechnology research company is filling a position for a Remote Regulatory Affairs Manager.

Individual must be able to fulfill the following responsibilities:

  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements
  • Implement and maintain current regulatory knowledge and advise management of significant developments

Qualifications Include:

  • Minimum of 3-5 years work experience in Regulatory Affairs
  • Experience and knowledge in preparation of INDs (required) and NDAs (desirable)
  • Experience with CTD/eCTD and understanding of FDA structure and function
  • Experience with publishing documents in Adobe Acrobat Professional
  • Working knowledge of FDA and ICH regulatory guidance and regulations
  • Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
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