Regulatory Affairs Intern

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

https://jobs.dayforcehcm.com/en-US/taiho/CANDIDATEPORTAL/jobs/4636