We have an exciting opportunity for a Regulatory Affairs Project Manager to join the team. The client is an established leader and operates globally.
Responsibilities:
- Assignment and management of resources
- Preparing documents for Module 1
- Coordinating Modules 2 and 3
- Tracking for Modules 4 and 5
- Managing MAA procedures and giving clients regulatory advice
- Project planning and management
- Request meetings for scientific advice for clients
- Interacting with Regulatory Agencies
Requirements:
- MSc or PhD in science or technology or medicine
- 10+ years experience in Regulatory Affairs and Project Management - ICH and FDA
- Software competency
- Strong communication skills and solution- orientated mindset
