Early Development Global Regulatory Lead

argenx

Ghent, Belgium or Remote, Switzerland

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.