Director, Regulatory Affairs

BeOne Medicines

. Develop, implement, and advise on North America regulatory strategies for development programs .

Posted 11/11/2026full-timeRemote • United StatesLead💰 $176,000 - $236,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Regulatory Affairs, particularly with FDA and Health Canada, and possesses a thorough understanding of the drug development process and regulatory requirements. Proven ability to lead regulatory strategies, manage teams, and effectively communicate complex regulatory issues.

Highest-signal resume keywords

Regulatory Affairs LeadershipFDA Interaction ExperienceINDs/CTAs and NDAs/BLAs ExpertiseRegulatory Strategy DevelopmentTeam Management and Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentINDs/CTAsNDAs/BLAsLifecycle ManagementRegulatory Team LeadershipRegulatory Policy DevelopmentClinical Study RequirementsMarket Access StrategiesRisk AssessmentRegulatory Documentation Preparation

Soft Skills

Strong Business AcumenExcellent Communication SkillsConflict Resolution SkillsNegotiation SkillsCreative Problem Solving

Tools & Technologies

Microsoft Office SuiteVeeva Regulatory Publishing

Industry Keywords

BiotechnologyPharmaceutical IndustryHealthcare EnvironmentRegulatory RequirementsHealth Authority InteractionsDrug Development ProcessMarket AccessPerformance ManagementCross-Functional Team CollaborationStakeholder Engagement

About the role

Key responsibilities & impact

Develop, implement, and advise on North America regulatory strategies for development programs
Secure and maintain market access in North America in line with business objectives
Coordinate with the global regulatory leader and key internal stakeholders
Manage North American regulatory aspects of compounds through development, post-approval, and product lifecycle phases
Provide leadership and strategic regulatory oversight for designated projects
Interface with the FDA, Health Canada, and business partners regarding development, regulatory, and registration strategies
Provide line management, people development, and performance management
Support and lead development and implementation of department policies
Provide regulatory strategic and operational direction and project mentorship
Advise on clinical study requirements, marketing approval, strategic development plans, risk assessments, critical issues, and health authority interactions
Oversee preparation and submission of investigational and marketing registration documentation in the US and Canada
Review clinical trial and marketing application documents and amendments for US and Canadian requirements
Liaise and negotiate with the FDA and Health Canada on drug development, regulatory issues, approvals, and labeling changes
Monitor the global regulatory environment and assess impacts on business and product development programs
Facilitate regulatory policy development and standard interpretation of global regulations
Integrate functional expertise with business knowledge to solve problems and support business decisions
Train, develop, and manage a regional regulatory team through direct and indirect reporting structures
Build partnerships with senior stakeholders across functions
Lead regulatory contributions to critical issues
Assist with development and implementation of regulatory processes
Recruit, develop, manage, and mentor regulatory professionals
Create a goal-oriented culture

Requirements

What you’ll need

10+ years of experience in the biotechnical or pharmaceutical industry
Minimum of 5 years’ experience in a Regulatory capacity with a broad background
Bachelor’s degree required
Experience working as a lead in Regulatory Affairs with the FDA preferred
Prior experience with both small molecules and biologics preferred
Thorough understanding of the drug development process, pharmaceutical industry, healthcare environment, regulatory requirements, and policy trends
Extensive experience with INDs/CTAs, NDAs/BLAs, lifecycle management, Health Authority interactions, regulatory team leadership, and regulatory strategy development
Proven track record of significant regulatory accomplishments
Strong business acumen and sound decision-making ability
Strong strategic skills, creativity, and ability to address strategic challenges
Ability to deliver goals within a cross-functional team/partnership environment
Excellent verbal and written communication skills
Ability to analyze, define, and communicate complex issues persuasively
Conflict resolution and negotiation skills
Strong negotiating skills and ability to develop creative solutions
Ability to build trust and respect within the organization
Ability to prioritize and handle multiple projects simultaneously
Experience with Microsoft Office suite
Experience with Veeva regulatory publishing
PowerPoint presentation authoring and presentation skills
Ability to interact with external business partners and regulatory agencies
Business travel availability of 10–20% as required

Benefits

Comp & perks

Annual bonus plan eligibility for non-commercial roles
Incentive compensation plan eligibility for 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
Equal opportunity employer
Reasonable accommodation in the job application process