Associate Director, Regulatory Affairs

BeOne Medicines

Associate Director managing regulatory projects at BeOne, an oncology company fighting cancer. Responsible for developing regulatory strategies and interacting with Health Authorities.

Posted 5/6/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $146,700 - $196,700 per yearWebsite

About the role

Key responsibilities & impact

Manage, evaluate, and complete regulatory projects
Develop, implement, and advise on regulatory strategies
Responsible for managing decision-making and conflict resolution
Oversee the preparation and submission of documentation
Liaise and negotiate with regulatory authorities
Maintain awareness of regulatory environment and assess impact of changes

Requirements

What you’ll need

Bachelor’s degree with 8+ years’ of related regulatory experience
Experience working as a Project Lead in Regulatory Affairs
Experience with INDs/CTAs, NDAs/BLAs/MAAs
Lifecycle management
Interactions with Health Authorities
Current knowledge of FDA perspectives, precedents, and guidances
Excellent verbal and written skills

Benefits

Comp & perks

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesINDsCTAsNDAsBLAsMAAslifecycle managementregulatory documentationproject managementconflict resolution

Soft Skills

decision-makingnegotiationcommunicationverbal skillswritten skills

Certifications

Bachelor’s degree