argenx · 3 weeks ago
Global Regulatory Lead
United States
Full-time
Remote
Director/Executive
15+ years expargenx is a global immunology company focused on developing antibody-based medicines for severe autoimmune diseases and cancer. They are seeking a Global Regulatory Lead to support the rapid growth necessary for successful commercialization, providing strategic regulatory insight and overseeing regulatory affairs throughout the product life cycle.
BiotechnologyClinical TrialsTherapeutics
Responsibilities
Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally
Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings
Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators
Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requested
Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user fees
Monitor, interpret, and communicate changes to the global regulatory landscape as required
Serve as the regulatory affairs business partner to local commercialization teams
Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams
Qualification
Required
Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA
A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in United States
Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
Affinity with science and ability to interact with scientists and clinicians
Experience interacting with regulatory authorities, especially the FDA and EMA
Ability to speak and interact with a diverse group of individuals on technical and business topics
Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
Track record of successful interactions with regulatory and health authorities
You are a connector, building relationships and partnering across the organization to achieve the company goals
You excel in a fast-paced, results-driven, highly accountable environment
You are pragmatic, yet creative and innovative and lead while 'rolling up your sleeves' to get it done
You show strong leadership with proven ability to build, motivate and develop a team
You resonate with the values of argenx and you are ready to drive the Company Culture
You combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goal
Preferred
PhD or PharmD preferred
Prior experience working in rapidly growing pharmaceutical organizations is desirable
Company
argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$3.75BKey Investors
Forbion Capital Partners
2023-07-18Post Ipo Equity· $1.1B
2022-03-23Post Ipo Equity· $700M
2021-02-02Post Ipo Equity· $999.38M
Leadership Team
Karen Massey
Chief Operating Officer
Carine Rivet-Thions
Associate Director Regulatory Affairs Labeling
Recent News
belganewsagency.eu
2026-01-16
2026-01-16
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