Job Summary

A clinical research organization has an open position for a Remote Junior Regulatory Consultant Strategist.

Core Responsibilities of this position include:

• Completing other routine and ad hoc analysis and reporting
• Documenting meetings, teleconferences and other interactions/communications
• Supporting PDR Program Manager in his/ her responsibilities

Qualifications Include:

• Support FDA meetings, support post marketing activities, representing regulatory at study team meetings
• Knowledge of GxP, ICH, and other regulatory guidelines
• Average of 3 or more years' relevant clinical experience in regulatory affairs
• Graduate (Bachelors) Degree required
• Knowledge of the drug development process and how other functions contribute
• Level of direct therapeutic area experience is role dependent