Intern – Regulatory Affairs (paid)

Location:        Burlingame, CA (SF Bay Area) – Requires 1 day a week in office
Timing:          May 15 to Aug 15 (flexible), approximately 20 hrs/week

About ArriVent:
ArriVent Biopharma is a biopharmaceutical company focused on the development of our investigational candidate, furmonertinib, which has promising clinical data in patients with non-small cell lung cancer with activating EGFR mutations.

Summary of the role:
The Regulatory Affairs Intern will support activities withing the Regulatory Affairs department over the course of three months. The intern will work closely with colleagues in Regulatory CMC, Clinical Regulatory Affairs, and have the opportunity to meet with cross-functional team members. The role is a hybrid model in which the intern is expected to be on site in the Burlingame office 1-2 days per week and work remotely for the remainder. This is a paid internship and all housing, travel, and meals are the responsibility of the intern.

Responsibilities Include:     

• Work on projects that improve collaboration, problem solving, and critical thinking skills
• Support ongoing Phase 1 through 3 clinical trials activities, preparation and compilation of submissions for regulatory agencies
• Assist with tracking of regulatory/ethics submissions and approvals across all studies, and document archiving
• Learn regulatory affairs competencies to ensure IND lifecycle process compliance
• Review of applicable regulatory and/or oncology Guidance Documents to research and gain understanding of the health authority viewpoint(s) as related to the topics of the project
• Review of Global Regulatory submission documents to obtain correspondence information and feedback between the company and the health authorities
• Review regulatory or oncology specific webinars, as available, on current hot topics to further learning in regulatory space

Preferred Qualifications:

• Must be pursuing or just completed Graduate Degree (Masters/PharmD/PhD) with Concentration(s) in the Life Sciences, Pharmaceutical Sciences
• Excellent oral and written communication skills. Experience with Microsoft Office applications Word, Excel, PowerPoint)
• Able to work close collaboration with colleagues
• Organized, detail oriented, and proactive.
• Familiar with MS Office Software, particularly Excel, Word, and PowerPoint