- Remote, United States
- Remote
- Full-time · Manager
- $168K–$198K per year
- 5+ years
Lead and manage global regulatory activities for Summit’s investigational therapy, ensuring compliance with FDA and international authorities while driving clinical development timelines.
Compensation
$168,000—$198,000 USD
Responsibilities
- Provide scientific and regulatory guidance to project teams at the clinical study level
- Assess, develop, and implement global regulatory strategies for ivonescimab
- Independently manage regulatory activities including CTA, IND, BLA, and MAA submissions
- Review and approve investigator document packages and FDA submissions
- Coordinate written responses to agency queries and track regulatory commitments
Requirements
- BA/BS in Biotechnology, Biological Sciences, or related field
- Graduate-level degree such as MS, PhD, or PharmD
- Nice to have: knowledge of Chinese
- Nice to have: experience with ex-US CTAs
- Nice to have: experience with ex-US health authority interactions