Job Summary
A pharmaceutical company is in need of a Remote Drug Regulatory Affairs Director.
Individual must be able to fulfill the following responsibilities:
- Establish and implement, in collaboration with leadership, global strategic regulatory goals
- Serve as primary contact for Regulatory Agency interactions for products
- Anticipate and identify regulatory risks and make recommendations
Skills and Requirements Include:
- Bachelor’s degree
- Minimum of 5 years of regulatory affairs experience
- A high level of familiarity and understanding of FDA and ICH regulations and guidelines
- Several years of experience in medical imaging drug development
- Good working knowledge of applicable regulations, such as GLP, GMP, GCP and OPDP regulations
