Associate Director/Director, Regulatory Project Management
Company Name: BridgeBio
Job Overview
This role involves leading and managing regulatory activities to support product development, approval, and post-marketing compliance.
Key Responsibilities:
- Developing global regulatory strategies
- Overseeing filings (INDs, NDAs, MAAs)
- Managing submission timelines
- Collaborating with cross-functional teams
Requirements:
- Bachelor's degree in a life science field
- At least 5 years of regulatory affairs experience in biotech/pharma
- Strong understanding of global regulatory requirements