Regulatory Affairs Intern

Summit Therapeutics Sub • Palo Alto, CA

14h • $25 - $35

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: An opportunity to spend your summer working with energetic colleagues and inspirational leaders, all while gaining hands-on experience in Regulatory Affairs. We are currently seeking a Regulatory Affairs Strategy Intern. This is a paid, full-time time position for the Summer 2025. The candidate will work closely with and report to the Regulatory Affairs Leadership team and will gain experience in the RA life cycle process. The candidate must commit to eight (8) weeks for internship.

Requirements

• Currently enrolled full-time in a graduate program (MD, PhD, PharmD), pursuing a degree majoring in a biological sciences, healthcare science (pharmacy or medical).
• Pharm D Students that are currently enrolled in P2 and P3 along with those that are enrolled in masters degree from an accredited DRA Program are also encouraged to apply.
• Possess an understanding of regulatory science and clinical drug development through coursework or experience.
• Demonstrate ability to work on teams.
• Strong interpersonal, verbal communication and writing skills.
• Strong analytical and problem-solving skills, ability to be resourceful
• Detail-oriented, highly ? motivated, able to manage multiple tasks and to work independently and as a team member.
• Possess proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Currently authorized to work in the United States without sponsorship.

Responsibilities

• Work with assigned mentors on projects to help improve leadership, problem solving, and critical thinking skills
• Assist with life-cycle regulatory activities
• Support projects overseen by regulatory leads; will be required to manage their time appropriately with some supervision
• Give a final presentation on assigned project
• Participate ? in certain department activities and initiatives related to the project.

What This Job Offers

• Job Type: Full-time
• Career Level: Intern