Associate Director, Global Regulatory Project Management

BeOne Medicines

Associate Director leading global regulatory submissions and cross-regional project execution. Advancing affordable oncology medicines at BeOne.

Posted 8/21/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $146,700 - $196,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory project management, including strategic oversight of global submissions and lifecycle management for both small molecules and biologics. Proven ability to lead cross-functional teams, optimize processes, and effectively communicate with stakeholders.

Highest-signal resume keywords

Regulatory Project ManagementGlobal Regulatory SubmissionsStrategic Regulatory LeadershipCross-Functional Team LeadershipPMP Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyIND/CTA SubmissionsNDA/BLA/MAA SubmissionsData Integration for Decision-MakingProcess Optimization

Soft Skills

Excellent Communication SkillsConflict ResolutionNegotiation SkillsStrategic ThinkingBusiness Acumen

Tools & Technologies

SmartsheetsMS ProjectPower BIMicrosoft OfficeElectronic Document Management Systems

Certifications & Qualifications

PMP Certification

Industry Keywords

Global Regulatory StrategiesDrug Development ProgramsInvestigational Registration DocumentationMarketing Registration DocumentationCross-Regional Teams

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Translate, implement, and advise on global regulatory strategies across drug development programs
Provide strategic regulatory oversight for global product development, submissions, and lifecycle management
Lead and manage complex IND/CTA, NDA/BLA/MAA regulatory submissions across multiple regions
Translate regulatory strategy into actionable project plans and drive operational execution
Coordinate cross-functional activities and ensure delivery on time
Organize and facilitate global cross-functional meetings
Identify risks, propose solutions, and manage critical regulatory submission issues
Oversee preparation and submission of investigational and marketing registration documentation
Build partnerships with senior stakeholders and clinical, medical, safety, CMC, and commercial teams
Liaise and negotiate with cross-functional teams to expedite submissions and resolve regulatory issues
Mentor and guide junior staff
Champion process optimization and contribute to regulatory processes and policies
Potentially supervise Regulatory Project Management staff and oversee global cross-functional project teams
Occasional travel to support global project teams, regulatory meetings, and industry conferences

Requirements

What you’ll need

Bachelor’s degree in Science or related discipline
Minimum 8+ years of experience in regulatory project management and regulatory submissions
Experience with both small molecules and biologics
Significant global exposure
Demonstrated strategic regulatory leadership and successful submissions in multiple regions
Experience leading cross-functional and cross-regional teams
Strong business acumen and strategic thinking
Ability to integrate multiple sources of data for decision-making
Excellent verbal and written communication skills
Skilled in conflict resolution and negotiation
Proficiency with Smartsheets, MS Project, Power BI, and Microsoft Office
Ability to learn and adapt to new software and digital collaboration tools
Experience with electronic document management systems and regulatory submission platforms preferred
PMP or similar certification preferred
Occasional international and domestic travel may be required

Benefits

Comp & perks

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