Intern – Regulatory Affairs, CMC

🕒 May 7

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• 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. • 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 CMC process improvements. • Support the drafting of CTD CMC sections to ensure on-time and high-quality global applications for direct submission to Health Authorities as needed. • Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed.

🎯 Requirements

• Active enrollment (Graduate or Ph.D.) in an accredited college or university pursuing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum 3.0 GPA • Awareness of processes for working in a regulated field preferred • Basic knowledge of healthcare industry and strong passion for biotech • Legally authorized to work in the United States without needing sponsorship for employment now or in the future • Ability to work independently on assignments with routine check-ins • Strong written and oral communication skills • Organized, responsible, resourceful, and detail-oriented • Able to work in a cross-cultural team environment with members across different time zones • Able to work remotely using MS TEAMS and other collaboration tools

🏖️ Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness