Early Development Global Regulatory Lead

pJoin 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. /ppWe 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. /ppFor the expansion of our regulatory team, argenx is looking for an Early Development Global Regulatory Lead, EDGRL, to support the rapid growth of its early-stage pipeline. /ph3Key Accountabilities and

Responsibilities:
/h3pThe ED-GRL is a key member of the global Early Development regulatory team (EDRT). 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 plays a critical role across the Early Development organization, acting as a key strategic advisor and enabler of accelerated, patient-centric development pathways. In close collaboration with cross-functional partners and the broader regulatory team, this role provides high-quality, timely regulatory guidance to support early asset progression-from pre-nomination activities and scientific advice through early clinical development and regulatory interactions-ensuring robust regulatory foundations and smooth transition into later-stage development. /ph3Your primary areas of focus are: /h3ulliAct as a key member of the EDRT establishing and growing the team in alignment with argenx culture /liliProvide global regulatory leadership for assigned early development programs, ensuring clear regulatory strategy, risk identification, and alignment of cross-functional teams. /liliCo-create and implement innovative global regulatory strategies to deliver expedited development milestones through end of first in human studies aligning with commercial objective /liliEnsure patient-centricity is embedded in regulatory strategy /liliRepresent EDRT within key early development governance forums and ensure consistent regulatory input across stakeholders in a timely manner to support business decisions /liliServe as the conduit between EDRT and asset teams to facilitate a smooth transition of programs /liliPartner with ED Regulatory Lead to develop and implement infrastructure and process improvements /liliMentor and coach EDRT members /liliBuild relationships with internal stakeholders /liliWork with regulatory intelligence and policy teams to monitor, interpret and communicate evolving global regulatory requirements /liliOversee regulatory affairs vendors involved in EDRT activities and ensure high-quality interactions with regulators /liliWork with the rest of the argenx ED teams, provide hands-on contributions to regulatory filings including Scientific Advice, INDs, and other areas as requested /li /ulh3Desired Skills and

Experience:
/h3ulliMinimum 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. /liliAdvanced scientific degree preferred, such as PhD or PharmD. /liliResonates with argenx values and culture, with a collaborative, humble and accountable approach to working across the organization. /liliStrong understanding of drug development, with direct experience in early clinical development, first-in-human studies, orphan drugs and regulatory strategy for innovative medicines. /liliProven ability to develop fit-for-purpose global regulatory strategies that support early asset progression, regulatory interactions and informed development decisions. /liliRegulatory experience across early and late clinical development phases, supporting continuity from discovery and first-in-human studies through later-stage development. /liliExperience interacting with regulatory authorities, including scientific advice, IND/CTA activities, expedited pathways and other early development regulatory milestones. /liliStrong scientific mindset, with the ability to engage credibly with scientists, clinicians and cross-functional development teams. /liliScientific depth in immunology is highly desirable, with broader experience across therapeutic areas, indications considered an advantage. /liliComplementary expertise across modalities, including antibodies, peptides, siRNA, and small molecules. /liliExperience integrating biomarker strategy, patient engagement and patient-relevant evidence into regulatory and development plans. /liliStrong understanding of current and