Regulatory Affairs Intern, CMC

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000 employees

Founded 1961

Description

• Updated and maintain accurate CMC information in the BeiGene Regulatory Information Management system • Data remediation • Creation and maintenance of CMC Submission Content • Uploading HA Correspondence/HA Questions/Commitments • Maintain internal Regulatory CMC trackers • Contribute to Regulatory 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 Regulatory 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 pursing a degree in a scientific discipline 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 • 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