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. /p pWe 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. /p pFor 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. /p h3Key Accountabilities And Responsibilities /h3 pThe 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. /p h3Your Primary Areas Of Focus Are /h3 ul liAct as a key member of the EDRT establishing and growing the team in alignment with argenx culture /li liProvide global regulatory leadership for assigned early development programs, ensuring clear regulatory strategy, risk identification, and alignment of cross-functional teams. /li liCo-create and implement innovative global regulatory strategies to deliver expedited development milestones through end of first in human studies aligning with commercial objective /li liEnsure patient-centricity is embedded in regulatory strategy /li liRepresent EDRT within key early development governance forums and ensure consistent regulatory input across stakeholders in a timely manner to support business decisions /li liServe as the conduit between EDRT and asset teams to facilitate a smooth transition of programs /li liPartner with ED Regulatory Lead to develop and implement infrastructure and process improvements /li liMentor and coach EDRT members /li liBuild relationships with internal stakeholders /li liWork with regulatory intelligence and policy teams to monitor, interpret and communicate evolving global regulatory requirements /li liOversee regulatory affairs vendors involved in EDRT activities and ensure high-quality interactions with regulators /li liWork 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 /ul h3Desired Skills And Experience /h3 ul liMinimum 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. /li liAdvanced scientific degree preferred, such as PhD or PharmD. /li liResonates with argenx values and culture, with a collaborative, humble and accountable approach to working across the organization. /li liStrong understanding of drug development, with direct experience in early clinical development, first-in-human studies, orphan drugs and regulatory strategy for innovative medicines. /li liProven ability to develop fit-for-purpose global regulatory strategies that support early asset progression, regulatory interactions and informed development decisions. /li liRegulatory experience across early and late clinical development phases, supporting continuity from discovery and first-in-human studies through later-stage development. /li liExperience interacting with regulatory authorities, including scientific advice, IND/CTA activities, expedited pathways and other early development regulatory milestones. /li liStrong scientific mindset, with the ability to engage credibly with scientists, clinicians and cross-functional development teams. /li liScientific depth in immunology is highly desirable, with broader experience across therapeutic areas, indications considered an advantage. /li liComplementary expertise across modalities, including antibodies, peptides, siRNA, and small molecules. /li liExperience integrating biomarker strategy, patient engagement and patient‑relevant evidence into regulatory and development plans. /li liStrong understanding of current and evolving global regulations, guidelines, and regulatory expectations and health care business practices relevant to early and late clinical development globally. /li liClear and influential communicator, with strong written, verbal and presentation skills and the ability to translate complex regulatory topics into practical business recommendations. /li liHighly developed organizational and project management skills, with the ability to prioritize, delegate and manage multiple workstreams in a fast‑paced environment. /li liStrong matrix leadership skills, with the ability to build relationships, influence stakeholders, build, motivate and develop teams, and drive outcomes. /li liPragmatic, creative and hands‑on, combining strategic thinking with the ability to execute and deliver high‑quality work under challenging timelines. /li liAdditional experience supporting cross‑functional business development due diligence activities and providing regulatory assessments to support investment and portfolio decisions is an advantage. /li liInterest in applying AI and digital tools to improve regulatory strategy, regulatory intelligence, document preparation and ways of working is an strong advantage. /li /ul h3Candidates must be located in Belgium or Switzerland to be considered for this role. /h3 pNote: The recruiter will share the locally applicable annual base salary hiring range, provided in your country’s currency, during the recruitment process. This information will reflect market conditions, role scope, and internal guidelines specific to your location. /p pThis job is eligible to participate in our short-term and long-term incentives program. /p pThe hiring range displayed above is the range of possible base pay compensation that argenx believes in good faith it will pay for this role at the time of this posting. The hiring range is based on the job grade for this position. Individual compensation paid within this range depends on a variety of factors, including, but not limited to, internal equity, prior education and experience, job‑related knowledge and demonstrated skills. argenx may pay more or less than the posted range and this range may be modified in the future. /p pAt argenx, all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer. /p pBefore you submit your application, CV or any other personal details to us, please review our argenx Privacy Notice for Job Applicants to learn more about how argenx B.V. and its affiliates (“argenx”) will handle and protect your personal data. If you have any questions or you wish to exercise your privacy rights, please contact our Global Privacy Office by email at /p #J-18808-Ljbffr