Job Summary
A staffing agency is searching for a person to fill their position for a Remote Senior Regulatory Affairs Manager in Baltimore.
Individual must be able to fulfill the following responsibilities:
- Reviewing non Clinical, Clinical and CMC, or general project management documents
- Acting as the regulatory lead and primary contact for the project team
- Providing guidance on overall impact / risks to the program
Skills and Requirements Include:
- Ability to travel for face to face meetings
- Ability to lead clinical submissions and health authority meetings
- Ability to provide guidance to SMEs on overall content strategy
