Intern – Regulatory Affairs, CMC
Description: • Support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members (Quality Assurance, Supply Chain, CMC, and IT) • Maintain accurate CMC information in the BeOne Regulatory Information Management system • Data remediation and creation and maintenance of CMC submission content • Upload HA Correspondence/HA Questions/Commitments • Maintain internal Regulatory CMC trackers • Contribute to Reg CMC process improvements • Support drafting of CTD CMC sections to ensure on-time and high-quality global applications • Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed • Gain hands-on experience preparing regulatory documents for submission to global health authorities and learn global regulatory differences 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.) • 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 • Able to work remotely using MS TEAMS and other collaboration tools • Proficient in Microsoft Office Benefits: • Non-Commercial roles are eligible to participate in the annual bonus plan • Commercial roles are eligible to participate in an incentive compensation plan • Opportunity to own shares of BeOne Medicines Ltd. stock (discretionary equity awards) • Voluntary participation in the Employee Stock Purchase Plan • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness Apply tot his job