Senior Manager, Regulatory Affairs

Summit Therapeutics Sub•Palo Alto, CA

5d•$174,000 - $204,000

About The Position

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. Summits 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. Summits team is inspired to touch and help change lives through Summits 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 Chinas 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: Reporting to Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

Requirements

BA/BS degree in the biological or health related sciences required, Masters, PhD or PharmD preferred
Minimum of 3+ years of experience in regulatory affairs
Minimum of 7+ years of pharmaceutical, biotechnology, or life sciences industry experience
Knowledgeable of US FDA and international pharmaceutical guidances, regulations, drug development process, and industry-standard practices
Possess strong written, oral communications
Demonstrate proven interpersonal skills and experience working cross-functionally throughout the organization
Detail-oriented, ability to work proactively, organize, prioritize, and delegate assigned projects
Experience interacting with CROs in the management of ex-US CTAs towards clinical trial activations preferred as well as ex-US health authority interactions, meetings etc.
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
Knowledge of Chinese is desirable

Responsibilities

Provide ownership of molecule and study-level regulatory activities, including global clinical trial applications (CTAs) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary
Contribute and drive the regulatory content and strategy for BLA, NDA or marketing authorization submissions
Provide regulatory guidance internally on study-team decisions
Update study team of regulatory activities in the context of study team management meetings
Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments
Collaborate with cross-functional study team for planning of regulatory documents, including health authority meetings and responses to health authority queries
Support processes by which regulatory submissions are reviewed, finalized, and signed-off
Manage the record of regulatory/ethics submissions and approvals across all studies
Manage document archive processes
Support global regulatory submissions and strategic planning as applicable
All other duties as assigned