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