Director, Regulatory Affairs

argenx

. Develop and implement robust US regulatory strategy for assigned projects .

Posted 9/22/2026full-timeRemote • United StatesLead💰 $212,000 - $291,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in US regulatory strategy development and implementation, with a strong focus on FDA interactions and compliance. Proven ability to lead cross-functional teams and manage complex regulatory submissions, ensuring alignment with evolving regulations and organizational goals.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Interaction ManagementDossier Preparation for INDs, BLAs, and NDAsStrategic Regulatory InputLeadership in Global Regulatory Roles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentSubmission Document ReviewDrug Development Process KnowledgeOrphan Drug ExpertiseRegulatory Compliance CoordinationLabeling Document DevelopmentData-Driven Insights UtilizationDigital Technologies UnderstandingProject Management SkillsResource Allocation

Soft Skills

Clear CommunicationStakeholder InfluenceTeam BuildingCoaching and MentoringStrategic Thinking

Certifications & Qualifications

PhDPharmD

Industry Keywords

Biopharmaceutical OrganizationsHealth Authority InteractionsRegulatory Landscape MonitoringCompetitive Landscape AnalysisClinical Protocols

About the role

Key responsibilities & impact

Develop and implement robust US regulatory strategy for assigned projects
Provide strategic, operational, and tactical regulatory input on pre-approval and post-approval activities focused on the US
Lead and facilitate activities related to regional strategy
Serve as primary contact with the FDA
Manage and lead health authority interactions, briefing packages, response documents, and FDA correspondence
Lead and oversee preparation of dossier content for INDs, BLAs, and NDAs
Critically review submission documents for regulatory compliance
Ensure timely, strategy-aligned responses to FDA questions
Participate in development of labeling documents including target product profile, CCDS, and USPI
Provide strategic regulatory input to clinical protocols, clinical and nonclinical reports, and summary documents
Partner with medical, legal, quality, pharmacovigilance, and distribution teams
Serve as Global Regulatory Lead on projects as needed
Monitor, interpret, and communicate changes to the US regulatory landscape
Monitor the competitive landscape, including regulatory precedents, labeling differences, and therapeutic-area issues

Requirements

What you’ll need

Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations
At least 5–7 years in global leadership roles with a focus on FDA
PhD or PharmD preferred
Prior experience working in rapidly growing pharmaceutical organizations is desirable
Thorough understanding of the drug development process
Expertise in orphan drugs
Knowledge of the developing landscape of regulations and guidelines globally
Demonstrated ability to coordinate critical regulatory documents involved in medicine approvals, with a focus on the FDA
Affinity with science and ability to interact with scientists and clinicians
Experience interacting with regulatory authorities
Ability to speak and interact with diverse individuals on technical and business topics
Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
Highly developed organizational and project management skills
Strategic planning, delegation, resource allocation, and workload prioritization skills
Understanding of digital technologies and AI-enabled environments
Ability to leverage data-driven insights and innovative tools to shape regulatory strategy
Clear communication and stakeholder influence skills
Outstanding presentation, written, and verbal communication skills
Experience with people management/coaching/mentoring preferred
Strong leadership with ability to build, motivate, and develop a team
Ability to combine strategic thinking with execution in a matrix environment
Ability to work in a fast-paced, results-driven, highly accountable environment
Ability to build relationships and partner across the organization
Alignment with argenx values and company culture

Benefits

Comp & perks

Short-term incentive programs
Long-term incentive programs
Retirement savings plans
Health benefits
Comprehensive benefits package
Equal consideration for employment without discrimination
Reasonable accommodation in completing the application, interviewing, or participating in the candidate selection process