Director, Regulatory Affairs CMC

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)
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.
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.
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 Director, Regulatory Affairs, CMC, is responsible for coordinating and preparing high-quality global regulatory filings. This role will provide regulatory strategy input and oversee preparation of regulatory submissions in collaboration with other stakeholders including CMC, Supply Chain and QA. The Director is responsible for providing regulatory guidance on Chemistry, Manufacturing and Controls (CMC) regulatory activities for assigned product(s) in coordination with key internal stakeholders. This role will manage regulatory CMC aspects of compounds (large molecules) through all phases of development and provide strategic and operational management of preparation and maintenance of CMC regulatory filings to support ongoing clinical activities as well as marketing applications.
Role and Responsibilities:
Develop and execute CMC regulatory strategies for Clinical Phase and Commercial Development as life cycle management.
Manages the preparation of high quality Regulatory CMC submissions including, IND, IMPD, BLA, MAA and post approval supplements as needed to meet global regulatory requirements.
Represent Regulatory CMC in project teams and provide strategic regulatory CMC input to ensure successful product development
Work closely with the CMC, Supply Chain, Quality and Regulatory Affairs team in the implementation of Regulatory Strategies to meet the Company Goals
Plan and participate in the preparation of Health Authority meeting requests, briefing books and responses to Health Authority information requests
Review CMC sections of regulatory submissions (IND, IMPD, BLA etc) for compliance with regulatory requirements and alignment with company strategies.
Lead and participate in Regulatory interactions with Health Authorities (HA), as appropriate.
Develop Regulatory CMC strategies and Risk assessments for assigned projects.
Identify areas of continuous process improvement and engage RA teams and key stakeholders as necessary.
Support in providing interpretation of global CMC regulations and guidelines, to Summit personnel for assigned programs
Provide support during Health Authority inspections as necessary.
Escalate issues that affect regulatory compliance, promptly to CMC RA Management
Maintain up to date knowledge of global regulations and guidances pertaining to CMC issues
Experience, Education and Specialized Knowledge and Skills:
Bachelor’s degree in chemistry, pharmacy, engineering, biochemistry or related science required. Master's Degree or other advanced degree preferred
10 or more years Regulatory CMC experience and/ or related Pharmaceutical industry experience required.
Experience in biologics required
Thorough and extensive knowledge of FDA, EU and global regulations required
Significant exper