Global Regulatory Lead

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October 7

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argenx

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Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

📋 Description

• Serve as a close business partner and facilitator of regulatory activities • Contribute to developing sound regulatory strategies globally • Play a critical role across the product life cycle and be a key advisor for successful product launches • Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally • Oversee regulatory affairs vendors involved in marketing authorization filings • Monitor, interpret, and communicate changes to the global regulatory landscape

🎯 Requirements

• 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 • PhD or PharmD preferred • Prior experience working in rapidly growing pharmaceutical organizations is desirable • A thorough understanding of the drug development process with expertise in orphan drugs • Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines • Experience interacting with regulatory authorities, especially the FDA and EMA • Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off