Intern - Regulatory Affairs, CMC (year-round)

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description/Scope of Responsibilities (Internship): BeOne is seeking a motivated and talented individual to join our Reg CMC small molecule team which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey. The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing to process optimization in knowledge management. Specifically, the intern will: Be exposed to the broad scope of global Regulatory Affairs and specifically CMC Regulatory Affairs and the role’s contribution to drug development and patients’ access to medicines. Learn about the role of global Health Authorities in the drug development process. Gain hands-on experience in preparing regulatory documents for submission to global health authorities. Acquire knowledge about the differences in regulatory requirements across regions. Experience CMC technical product development and manufacturing functions in relation to regulatory affairs. Essential Functions of the Internship: Responsible for maintaining accurate CMC information in the BeOne Regulatory Information Management system Data remediation Create and maintain CMC Submission Content Upload HA Correspondence/HA Questions/Commitments Maintain internal Regulatory CMC trackers Contribute to Reg CM