Job Overview
Location
Remote (US)
Job Type
Full-time
Category
HR & Recruiting
Date Posted
April 13, 2026
Full Job Description
📋 Description
- • The Associate Manager, Regulatory Affairs at BeiGene, Ltd. plays a critical role in advancing the company’s mission to fight cancer by managing and coordinating regulatory submissions and strategies that enable timely approvals of investigational and commercial products in the US and global markets.
- • Day to day, the individual will plan and manage regulatory activities with minimal supervision, prepare and submit regulatory dossiers (including INDs, BLAs/NDAs, supplements, annual and safety reports), support meeting requests and briefing documents, maintain regulatory archives, and provide regulatory guidance to cross-functional project teams.
- • BeiGene is a rapidly growing global biotechnology company dedicated to discovering, developing, and commercializing innovative medicines for cancer patients, with a strong commitment to scientific excellence, collaboration, and patient-centric values.
- • In this role, the person will deepen expertise in global regulatory requirements, enhance project management and cross-functional collaboration skills, contribute to meaningful oncology drug development initiatives, and grow as a regulatory leader within a mission-driven organization.
🎯 Requirements
- • BA/BS in Health Science or related field
- • 4+ years of experience in the pharmaceutical industry, preferably in regulatory affairs
- • Proficiency in Microsoft Word, Excel, and PowerPoint
- • Ability to manage regulatory submissions (INDs, BLAs/NDAs, annual reports) with minimal supervision
- • Strong understanding of clinical and non-clinical regulatory requirements
- • Experience working with cross-functional teams and external consultants/CROs
🏖️ Benefits
- • Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, and Life Insurance
- • Paid Time Off and Wellness programs
- • Opportunity to own company shares through discretionary equity awards and Employee Stock Purchase Plan
- • Eligibility for annual bonus plan (for non-commercial roles)
- • Commitment to fair and equitable compensation practices
- • Equal opportunity employer with support for reasonable accommodations
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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