Early Development Global Regulatory Lead

argenx US; Oost-Vlaanderen; On-site; EUR 120,000 - 180,000; Full time

Job summary

argenx is expanding its regulatory team and seeks an Early Development Global Regulatory Lead to drive global regulatory strategies for its early development portfolio, including first-in-human studies and orphan indications.

The role partners with cross-functional teams and regulators to accelerate patient access, ensure robust regulatory foundations, and guide programs from pre-nomination through early clinical development and regulatory interactions.

Qualifications

• Minimum 15 years of regulatory affairs experience in biopharma, with 5–7 years in global leadership roles (FDA/EMA/PMDA).
• Experience in early development, first-in-human studies, and orphan drugs.
• Experience with regulatory strategy, scientific advice, IND/CTA activities, and expedited pathways.

Responsibilities

• Provide global regulatory leadership for assigned early development programs.
• Co-create and implement global regulatory strategies to deliver expedited milestones.
• Ensure patient-centric regulatory strategy across development.
• Interact with regulatory authorities for scientific advice and regulatory submissions (IND/CTA).
• Oversee regulatory filings and vendor interactions; mentor EDRT members.

Skills

Global regulatory leadership

Regulatory strategy

Cross-functional collaboration

Regulatory filings

Stakeholder management

Education

PhD or PharmD preferred

Job description

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.

For 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.

Key Accountabilities and Responsibilities:

The 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.

Your primary areas of focus are:

• Act as a key member of the EDRT establishing and growing the team in alignment with argenx culture
• Provide global regulatory leadership for assigned early development programs, ensuring clear regulatory strategy, risk identification, and alignment of cross-functional teams.
• Co-create and implement innovative global regulatory strategies to deliver expedited development milestones through end of first in human studies aligning with commercial objective
• Ensure patient-centricity is embedded in regulatory strategy
• Represent EDRT within key early development governance forums and ensure consistent regulatory input across stakeholders in a timely manner to support business decisions
• Serve as the conduit between EDRT and asset teams to facilitate a smooth transition of programs
• Partner with ED Regulatory Lead to develop and implement infrastructure and process improvements
• Mentor and coach EDRT members
• Build relationships with internal stakeholders
• Work with regulatory intelligence and policy teams to monitor, interpret and communicate evolving global regulatory requirements
• Oversee regulatory affairs vendors involved in EDRT activities and ensure high-quality interactions with regulators
• Work with the rest of the argenx ED teams, provide hands-on contributions to regulatory filings including Scientific Advice, INDs, and other areas as requested

Desired Skills and Experience :

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