Senior Manager, Regulatory Affairs

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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:

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 3ificante study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first‑line metastatic.awtextra relevant NSCLC.

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.

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 studiesoshould be supported, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

• Provide ownership
  
  Security 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
• Support global regulatory submissions and strategic planning as applicable
• All other duties as assigned

• BA/BS degree in the biological or health related sciences required, Master’s, PhD or Pharm
  
  D 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…