Senior Associate, Regulatory Affairs

BeOne Medicines

Senior Associate plans and executes U.S. regulatory submissions for FDA compliance.

Posted 5/15/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $41 - $53 per hourWebsite

About the role

Key responsibilities & impact

Coordinate preparation and execution of US regulatory submissions (INDs, NDAs, BLAs, amendments, supplements) in compliance with FDA regulations and guidance.
Draft regulatory submission documents (e.g., IND components) as required.
Review regulatory documentation to ensure accuracy, consistency, and completeness, and supports the effective execution of regulatory submissions to health authorities.
Serve as the primary execution lead and cross-functional coordinator for assigned U.S. regulatory submissions, ensuring clarity of roles, timelines, and deliverables.
Partner with U.S. Regulatory Strategists to translate regulatory plans into executable submission timelines and deliverable strategies.
Collaborate with Clinical, CMC, Safety, Nonclinical, Medical Writing, Labeling, and to collect and organize FDA submission-ready documents.
Perform Quality control (QC) checks to ensure accuracy, consistency, and compliance with eCTD technical specifications and FDA requirements.
Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions.

Requirements

What you’ll need

BA/BS degree, preferably in a scientific or health-related discipline OR 3+ years of Regulatory Affairs experience, including hands-on support of U.S. IND preparation required.
Experience with CTD/eCTD.
Experience with publishing documents in Adobe Acrobat Professional.
Understanding of FDA structure and working knowledge of FDA and ICH regulatory guidance and regulations is desirable.
Ability to manage multiple US submissions and priorities simultaneously.
Strong organizational and documentation skills.
Ability to work independently and collaboratively under tight FDA-driven timelines.

Benefits

Comp & perks

Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Employee Stock Purchase Plan
Discretionary equity awards

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsIND preparationCTDeCTDquality controlregulatory documentationFDA regulationsICH regulatory guidancedocument publishingsubmission timelines

Soft Skills

organizational skillsdocumentation skillsindependent workcollaborative worktime management