Job Summary
A staffing agency has an open position for a Remote Pharmaceutical Regulatory Affairs Director.
Core Responsibilities Include:
- Developing US regulatory strategies to support successful biomarker-driven global clinical development
- Evaluating and defining regulatory requirements needed for clinical trial applications
- Coordinating the preparation and regulatory review of documents for regulatory submissions
Qualifications for this position include:
- Minimum Bachelor’s degree in a scientific discipline, advanced scientific degree preferred
- A minimum of 5 years of direct responsibility for regulatory affairs
- At least 8 or more years of drug development experience
- Strong knowledge of regulations/guidelines governing the development of pharmaceuticals
- Experience working with international regulatory agencies
- Willingness to work a flexible schedule/hours
