Remote Senior Regulatory Affairs CMC Scientist Manager

Job Summary

A clinical research organization is searching for a person to fill their position for a Remote Senior Regulatory Affairs CMC Scientist Manager.

Core Responsibilities Include:

• Planning, executing and managing regulatory submissions for assigned compounds in various phases
• Defining CMC content (data and documentation) requirements for regulatory submissions
• Evaluating change proposals for regulatory impact and filing requirements

Required Skills:

• Bachelor’s degree in relevant field of study
• 5-8 years of relevant experience
• Advanced knowledge of regulatory CMC requirements for global drug development
• Excellent presentation skills and ability to communicate effectively at multiple levels of the organization
• Ability to provide strategic regulatory guidance to drug development, registration, and postmarket support teams
• Ability to problem solve and apply skills to determine risk exposure and communicate