Global Regulatory Lead

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start‑up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients.

argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases and cancer. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world‑class portfolio of first‑in‑class antibodies in both early and late clinical‑stages of development. Our employees are self‑disciplined, hardworking, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they are the cornerstone of argenx.

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For the expansion of our regulatory team, argenx is looking for a Global Regulatory Lead, based in either Belgium, Switzerland or the East Coast of the US, to support the rapid growth needed for successful commercialization.

The Director GRL is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization.

In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre‑approval activities, to filing, distribution, and post‑approval regulatory activities, among others.

Your primary areas of focus are:

• 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

• 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 Pharm
  
  D preferred
• Prior experience working in rapidly growing pharmaceutical organizations is desirable
• 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
• A…