Intern, Regulatory Affairs

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.

Performance Objectives

• 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
  
  

Education/Certification 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.
  
  

Knowledge, Skills, And Abilities

• 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
  
  

The pay range for this position at commencement of employment is expected to be between $18 - $22 hourly. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

#Location-Pleasanton,CA

Equal Opportunity Employer Information: Taiho Oncology is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law. Any applicant who, because of a disability, needs an accommodation or assistance in completing an application or at any time during the application process, please email People@taihooncology.com. Taiho Oncology also provides reasonable accommodations to employees with disabilities consistent with our obligations under the law. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

The incumbent in this position may be required to perform other duties, as assigned.