Senior Manager, Regulatory Affairs

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. We believe in building a team of world class professionals who are passionate about this mission, and our people 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 the heart and soul of our culture and 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 study evaluating ivonescimab with chemotherapy versus placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC previously treated with a 3rd generation EGFR TKI.
• HARMONi-3:
  Phase 3 study evaluating ivonescimab with chemotherapy versus pembrolizumab with chemotherapy in patients with first-line metastatic NSCLC.
• HARMONi-7:
  Phase 3 study evaluating ivonescimab monotherapy versus pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

• HARMONi-GI3:
  Phase 3 study evaluating ivonescimab in combination with chemotherapy versus bevacizumab with 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, with additional offices in California, New Jersey, the UK, and Ireland.

Reporting to the Head of Regulatory Affairs, the Senior Manager of Regulatory Affairs will support the day-to-day regulatory activities of assigned projects. These projects include support of preparation and compilation of submissions for regulatory agencies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

• 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 management of 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 on regulatory activities in the context of study team management meetings.
• Manage and track inquiries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to inquiries, and provide periodic status updates regarding unfulfilled conditions/commitments.
• Collaborate with cross-functional study teams 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.

• 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.
• Knowledge of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry-standard practices.
• Strong written and oral communication skills.
• Proven interpersonal skills and experience working cross-functionally across the organization.
• Detail-oriented, proactive, organized, able to prioritize and delegate assigned projects.
• Experience interacting with CROs in the management…