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Overview of Role:
- Develops global regulatory strategies and submissions for Summit products.
- Provides regulatory leadership for product development and commercialization.
Role and Responsibilities:
- Oversees CMC regulatory strategies for biologics and health authority interactions.
- Leads submissions (IND, BLA, MAA) and post-approval activities.
Experience and Education:
- Bachelor's degree in science; advanced degree preferred.
- Over 15 years regulatory CMC experience; proficiency in Mandarin Chinese highly desirable.
Summit Therapeutics Inc.
Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and resolving unmet medical needs. They have a global presence with multiple Phase 3 clinical studies and an employee-driven culture centered on integrity and passion for excellence.