Job Summary
A staffing agency has an open position for a Remote Regulatory Affairs Director.
Candidates will be responsible for the following:
- Successfully responds to the regulatory authority and business partner questions and concerns
- Provides regulatory leadership and develops regulatory strategies for products
- Develops and implements regulatory submission project and resourcing plans
Must meet the following requirements for consideration:
- Prior experience interacting directly with FDA regulators
- 8 years of regulatory experience in drug development and registration activities
- Strong project management and computer skills (including Microsoft office)
- Full lifecycle experience from early development to managing marketed products
- BS, in science or a related discipline
