Director, Global Regulatory Project Management

BeOne Medicines

. Support, translate, and implement global regulatory strategies across drug development programs .

Posted 10/30/2026full-timeRemote • United StatesLead💰 $176,000 - $236,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in regulatory project management and submissions, with a strong focus on strategic leadership and cross-functional collaboration. Proficient in developing and implementing regulatory processes while effectively managing complex submission activities across multiple regions.

Highest-signal resume keywords

Regulatory Project ManagementIND/CTA, NDA/BLA/MAA SubmissionsCross-Functional Team LeadershipStrategic Regulatory LeadershipPMP Certification

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsProject ManagementData IntegrationConflict ResolutionNegotiation SkillsSmall Molecules ExperienceBiologics ExperienceRegulatory Processes DevelopmentDocument ManagementStrategic Thinking

Soft Skills

Excellent Communication SkillsMentoringBusiness AcumenAdaptability

Tools & Technologies

SmartsheetsMS ProjectPower BIMicrosoft Office SuiteElectronic Document Management Systems

Certifications & Qualifications

PMP CertificationAdvanced Degree Preferred

Industry Keywords

Global Regulatory StrategiesDrug Development ProgramsLifecycle ManagementInvestigational DocumentationMarketing Registration DocumentationCross-Regional TeamsRegulatory Authorities LiaisonProject-Management Process Improvements

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Support, translate, and implement global regulatory strategies across drug development programs
Advise Global and Regional Regulatory Leads on product development, submissions, and lifecycle management
Lead 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 meetings and track submission activities
Identify risks, propose solutions, and manage critical submission issues
Oversee preparation and submission of investigational and marketing registration documentation
Build partnerships with clinical, medical, safety, CMC, and commercial teams
Liaise and negotiate with cross-functional teams and regulatory authorities
Mentor and develop junior and mid-level staff
Champion regulatory project-management process improvements
Develop and implement regulatory processes and policies

Requirements

What you’ll need

Bachelor’s degree in Science or related discipline
Minimum 10+ 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
Ability to understand and translate complex regulatory issues
Conflict resolution and negotiation skills
Proficiency with project management and document management tools, such as Smartsheets, MS Project, and Power BI
Advanced skills in Microsoft Office suite (Word, Excel, PowerPoint, Outlook)
Ability to learn and adapt to new software platforms and digital collaboration tools
Experience with electronic document management systems and regulatory submission platforms is preferred
Advanced degree preferred
PMP or similar certification preferred

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for 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 benefits
Occasional international and domestic travel may be required