Regulatory Director
Posted 10 Sep 2026
Advertised as “Senior Director, Regulatory CMC ”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 15+ yrs
- Management level
- People management
- Employment
- Remote
No salary listed for this role.
Field of studyBiochemistry, Chemistry, Engineering, Pharmacy (or related)
Study levelBachelor's
Study levelMaster's or higher
About Summit:
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.
Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including:
Non-small Cell Lung Cancer (NSCLC)
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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.
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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.
Colorectal Cancer (CRC)
- HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.
Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Overview of Role:
The Senior Director, Regulatory Affairs, CMC, is responsible for developing Regulatory Strategies and Submissions for Summit products globally. This role will provide regulatory strategy leadership, for development, commercialization and life cycle management of Summit products.
The Senior Director will work in close collaboration with cross functional teams including Manufacturing, Analytical, Supply Chain and Quality to develop regulatory strategies aligned with company goals. The Senior Director will bring hands on experience leading regulatory CMC programs in biologics and demonstrated leadership skills. This role is both strategic and hands-on and will be responsible for all the regulatory CMC activities.