Early Development 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. 

For the expansion of our regulatory team, argenx is looking for an Early Development Global Regulatory Lead, based in Europe, 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

• Co-creation and implementation of innovative global regulatory strategies to deliver expedited development milestones through end of first in human studies to align with commercial objectives

• 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 matter 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

• Working 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

• 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, along with knowledge of the developing landscape of regulations and guidelines, specifically in United States

• Affinity with science and ability to interact with scientists and clinicians

• Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA

• Experience interacting with regulatory authorities, especially the FDA and EMA

• Ability to speak and interact with a diverse group of individuals on technical and business topics

• Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally

• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization

• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills

• Track record of successful interactions with regulatory and health authorities

• You are a connector, building relationships and partnering across the organization to achieve the company goals

• You excel in a fast-paced, results-driven, highly accountable environment

• You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done

• You show strong leadership with proven ability to build, motivate and develop a team

• You resonate with the values of argenx and you are ready to drive the Company Culture

• You combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goal.

Offer

• You’ll work in a successful and rapidly growing biotech company, where we foster a dynamic and supportive work environment.

• This is a full-time position, you’ll be part of a growing team with plenty of opportunities to make an impact.

• We offer a competitive salary package that comes with a broad range of benefits.

At 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.

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