Intern, Regulatory Affairs
About The Position
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho’s success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It’s our work, our passion, and our legacy. We invite you to join us. Hybrid Employee Value Proposition: Are you a motivated and enthusiastic college student looking to join our Regulatory Affairs team as an intern?This internship offers a unique opportunity for a motivated college student to gain hands-on experience in regulatory affairs/pharmaceutical industry by contributing to regulatory/FDA/health authority research projects within a dynamic and collaborative team. Position Summary: This internship would offer valuable experience in the field of regulatory affairs, specifically focusing on interactions within the pharmaceutical industry with US Food & Drug Administration (FDA), Health Canada (HC), and/or European Medicinal Agency (EMA). The intern will work closely with the regulatory affairs team to support submissions of various documents within regulatory/clinical/chemistry and manufacturing controls (CMC) to regulatory agencies.
Requirements
- In a Bachelor's degree program, rising junior or senior.
- Major in a scientific field, i.e., chemistry, biology, biochemistry, pharmaceutical sciences, health sciences, regulatory sciences, environmental studies, and/or any related science discipline.
- Strong academic background with coursework in chemistry, biochemistry, biology, pharmaceutical sciences, and/or related science disciplines
- Excellent analytical and problem-solving skills, with the ability to interpret and analyze scientific data
- Proficiency in Microsoft Office applications, particularly Excel, Word, and PowerPoint.
- Effective communication skills, both written and verbal, with the ability to effectively communicate technical information to diverse audiences
- Detail-oriented with strong organizational skills and the ability to manage multiple tasks simultaneously
- Ability to work independently as well as collaboratively within a team environment
Responsibilities
- Participate in literature review and research to support regulatory projects
- Support thereview and draft CMC information re. manufacturing or testing of investigational oncology drug for submission to regulatory agencies
- Assist in preparing regulatory information presentations at technical team meetings
- Help ensure that the pharmaceutical development, manufacturing and testing of drug substance and drug product conforms to current global regulatory requirements
- Attend team meetings, training sessions, and other departmental activities as required
- Adhere to all relevant regulatory guidelines, protocols, and standard operating procedures (SOPs) to ensure compliance with pharmaceutical industry standards
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What This Job Offers
Career Level
Intern
Number of Employees
251-500 employees
