Job Summary

A clinical and scientific staffing company is in need of a Telecommute Regulatory Affairs Director.

Individual must be able to fulfill the following responsibilities:

• Serve as a representative of Regulatory Affairs on Project Development Teams (PDT) for assigned products
• Direct the preparation and submission of regulatory agency applications, reports or correspondence
• Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards

Must meet the following requirements for consideration:

• Ability to lead regulatory submission process
• Able to engage external regulatory consultants for strategy advice and operational support
• Familiar with submission plans, generation and sign-off of key regulatory / response documents