Regulatory Affairs Intern
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Job Location:
Palo Alto, CA - USA
Hourly Salary:
$ 25 - 35
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
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.
Role and 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
- Participatein certain department activities and initiatives related to the project.
Experience Education and Specialized Knowledge and Skills:
- 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 highlymotivated 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.
The pay range for this role is $25-$35 per hourly. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Intern
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Summit is committed to leadership in resolving serious, unmet medical needs in oncology for the betterment of overall HUMAN HEALTH. Stifel Fireside Chat Patients & Caregivers Summit Latest News Committed to Optimizing Human Health Summit Therapeutics Inc. is a biopharmaceutical oncolo ... View more
