Remote Regulatory Affairs Manager in Madison

Location: New Jersey

Compensation: To Be Discussed

Staff Reviewed: Wed, Nov 11, 2020

This job expires in 15 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Staffing Agency

Job Summary

An information technology consultancy is seeking a Remote Regulatory Affairs Manager in Madison.

Individual must be able to fulfill the following responsibilities:

  • Carry out managerial responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws
  • Direct, coordinate and prioritize the daily activities of the assigned staff
  • Review and approve regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration

Required Skills:

  • FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations
  • Pertinent Federal and State laws related to pharmaceutical regulatory affairs
  • Supervision and training practices and methods
  • Business, scientific and personal computer software applications
  • Business English usage such as, spelling, grammar and punctuation