Associate Director, Regulatory Affairs

argenx

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

Posted 9/22/2026full-timeRemote • United StatesSenior💰 $164,000 - $225,500 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 critical regulatory documents throughout the drug development process.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA InteractionGlobal Leadership RolesDrug Development ProcessOrphan Drug Expertise

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentDossier Preparation for INDs, BLAs, and NDAsRegulatory Compliance ReviewClinical Study Design InputRegulatory Document Coordination

Soft Skills

Strategic ThinkingProject ManagementCommunication SkillsRelationship BuildingInnovative Problem Solving

Tools & Technologies

Digital TechnologiesAI-Enabled Environments

Certifications & Qualifications

PhDPharmD

Industry Keywords

BiopharmaceuticalsRegulatory LandscapeGlobal Health Care PracticesFDA GuidelinesPharmaceutical Organizations

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
Lead or participate in FDA meetings and prepare company personnel for FDA interactions
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 labeling document development and negotiation strategies
Provide input into clinical study design strategy
Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input for business decisions
Monitor, interpret, and communicate changes to the US regulatory landscape
Monitor competitive landscape, including regulatory precedents, labeling differences, and therapeutic-area issues
Contribute to global regulatory strategies across the product life cycle
Advise and enable product launches and commercialization

Requirements

What you’ll need

Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations
At least 3–5 years in global leadership roles with a focus on FDA
PhD or PharmD preferred
Prior experience in rapidly growing pharmaceutical organizations 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 for medicine approvals, focused on FDA
Affinity with science and ability to interact with scientists and clinicians
Experience interacting with regulatory authorities required
Ability to speak and interact with diverse individuals on technical and business topics
Familiarity with current and emerging regulatory legislation, industry trends, and global health care business practices
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
Clear written, verbal, and presentation communication skills
Ability to build relationships and partner across the organization
Ability to work in a fast-paced, results-driven, highly accountable environment
Pragmatic, creative, and innovative approach
Strong leadership and ability to build, motivate, and develop a team
Alignment with argenx values and company culture
Strategic thinking and ability to execute individually and by leading teams in a matrix environment

Benefits

Comp & perks

Short-term incentive programs
Long-term incentive programs
Retirement savings plans
Health benefits
Other benefits subject to applicable plans and program guidelines
Equal consideration in an inclusive, non-discriminatory environment
Reasonable accommodation in the application and selection process