Telecommute Regulatory Strategist

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Fri, Oct 16, 2020

This job expires in 17 days

Remote Level: 100% Remote

Employer Type: Employer

Education Level: Bachelors, Masters, Doctorate

Job Summary

A clinical research organization has a current position open for a Telecommute Regulatory Strategist.

Individual must be able to fulfill the following responsibilities:

  • Provide consulting services in regulatory program strategy, overall drug development plans, strategic regulatory communications, and FDA representation
  • Oversee the Regulatory Affairs aspects of client projects and project teams
  • Write, review, and provide strategic regulatory guidance on alternative pathways

Qualifications Include:

  • Bachelor’s degree in a related field required. Advanced scientific degree (i.e. PhD or Master’s degree) preferred
  • 10 years of relevant experience with at least 5 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting required
  • Knowledge of International Conference on Harmonisation (ICH) guidelines and other applicable regulatory rules
  • Experience serving as an authorized regulatory representative required
  • Excellent written and oral communication skills including grammatical/technical writing skills