Job Overview
Location
Remote (US)
Job Type
Full-time
Category
Product Management
Date Posted
May 7, 2026
Full Job Description
đź“‹ Description
- • 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.
- • Day-to-day responsibilities include maintaining accurate CMC information in the BeOne Regulatory Information Management system, performing data remediation, creating and maintaining CMC submission content, uploading HA correspondence and questions, maintaining internal regulatory CMC trackers, contributing to process improvements, and supporting the drafting of CTD CMC sections for global submissions.
- • The intern will join BeiGene’s Reg CMC small molecule team, which offers meaningful project experiences that provide valuable biotech exposure as interns complete their academic journey. The team emphasizes collaboration, scientific rigor, and a shared passion for fighting cancer.
- • The intern will gain hands-on experience in preparing regulatory documents for global health authorities, understand regional regulatory differences, learn about the role of health authorities in drug development, and develop skills in CMC technical product development and manufacturing as they relate to regulatory affairs. This role offers the opportunity to contribute to process optimization and build foundational expertise in regulatory affairs within a growing global biotech company.
🏖️ Benefits
- • Opportunity to gain valuable biotech experience and contribute to meaningful regulatory projects
- • Exposure to global regulatory affairs and CMC processes in a professional work environment
- • Access to BeiGene’s comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness (as applicable to employee status)
- • Eligibility for discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan
- • Remote work flexibility using MS Teams and other collaboration tools
- • Commitment to fair and equitable compensation practices
Skills & Technologies
About BeiGene, Ltd.
BeiGene is a global biotechnology company discovering, developing, manufacturing and commercializing innovative oncology medicines. Its broad pipeline includes more than 50 clinical-stage molecules, spanning targeted therapy, immuno-oncology and combination regimens. Core products are BTK inhibitor BRUKINSA, PD-1 antibody tislelizumab and PARP inhibitor pamiparib, marketed worldwide through internal teams and strategic alliances. BeiGene operates integrated research campuses in Beijing and Cambridge, MA, a manufacturing facility in Suzhou and offices across North America, Europe and Asia-Pacific, serving patients in more than 45 countries.
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