Intern – Regulatory Affairs, CMC

September 18

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Logo of BeOne Medicines

BeOne Medicines

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.

10,000+ employees

Founded 2010

📋 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

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