Senior Associate, Regulatory Affairs

BeOne Medicines

. Plan, track, and execute U.S.

Posted 11/5/2026full-timeRemote • United StatesSenior💰 $93,600 - $123,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in U.S. regulatory submissions, including IND, NDA, and BLA preparation, with a strong focus on compliance and quality control. Proficient in managing submission timelines and collaborating with cross-functional teams to ensure timely and accurate regulatory documentation.

Highest-signal resume keywords

U.S. Regulatory SubmissionsIND PreparationFDA SubmissionsECTD ExperienceVeeva Vault RIM

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory DocumentationQuality Control ChecksSubmission Timeline ManagementDocument IntegrityFDA Guidance Knowledge

Soft Skills

Strong Organizational SkillsAbility to Work IndependentlyCollaborative Teamwork

Tools & Technologies

Veeva Vault BRIMAdobe Acrobat ProfessionalMicrosoft Office

Industry Keywords

Regulatory AffairsINDNDABLAICH Regulations

Tech Stack

Tools & technologies

AssemblyVault

About the role

Key responsibilities & impact

Plan, track, and execute U.S. regulatory submissions to the FDA for investigational and commercial products
Coordinate preparation and execution of INDs, NDAs, BLAs, amendments, and supplements
Draft regulatory submission documents, including IND components
Review regulatory documentation for accuracy, consistency, and completeness
Serve as primary execution lead and cross-functional coordinator for assigned U.S. submissions
Translate regulatory plans into executable submission timelines and deliverable strategies with U.S. Regulatory Strategists
Collect and organize FDA submission-ready documents with Clinical, CMC, Safety, Nonclinical, Medical Writing, and Labeling teams
Perform quality-control checks for eCTD technical specifications and FDA requirements
Liaise with Regulatory Publishing to support on-time, first-cycle-quality FDA submissions
Maintain IND, NDA, and BLA archives, version control, document integrity, and inspection readiness
Request FDA application numbers through the CDER NextGen Portal and track FDA correspondence
Use Veeva Vault RIM and submission trackers to monitor milestones, deliverables, and risks
Monitor FDA guidance updates and contribute to continuous improvement of U.S. submission processes
Support regulatory strategies for earliest possible approvals or clearances
Manage preparation, writing, assembly, review, and timely submission of regulatory dossiers in the U.S. and abroad

Requirements

What you’ll need

BA/BS degree, preferably in a scientific or health-related discipline, with 2+ years of experience OR 5+ years of Regulatory Affairs experience, including hands-on support of U.S. IND preparation (required)
3+ years of direct experience preparing and executing FDA submissions (IND, NDA, BLA) and lifecycle management activities
Prior Regulatory Affairs experience; hands-on support of U.S. IND preparation and working knowledge of NDA submissions and related amendments or supplements
Experience with CTD/eCTD
Experience publishing documents in Adobe Acrobat Professional
Working knowledge of FDA and ICH regulatory guidance and regulations is desirable
Familiarity with regulatory systems such as Veeva Vault BRIM and document management tools
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Ability to manage submission timelines, trackers, and Master Document Lists
Strong organizational and documentation skills
Ability to manage multiple U.S. submissions and priorities simultaneously
Ability to work independently and collaboratively under tight FDA-driven timelines

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Discretionary equity awards
Voluntary participation in the Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness benefits