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:
1. Act as a key member of the EDRT establishing and growing the team in alignment with argenx culture
2. 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
3. Ensure patient-centricity is embedded in regulatory strategy
4. Represent EDRT within key early development governance forums and ensure consistent regulatory input across stakeholders in a timely matter to support business decisions
5. Serve as the conduit between EDRT and asset teams to facilitate a smooth transition of programs
6. Partner with ED Regulatory Lead to develop and implement infrastructure and process improvements
7. Mentor and coach EDRT members
8. Build relationships with internal stakeholders
9. Work with regulatory intelligence and policy teams to monitor, interpret and communicate evolving global regulatory requirements
10. Oversee regulatory affairs vendors involved in EDRT activities and ensure high quality interactions with regulators
11. 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:
12. 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
13. PhD or PharmD preferred
14. Prior experience working in rapidly growing pharmaceutical organizations is desirable
15. 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
16. Affinity with science and ability to interact with scientists and clinicians
17. Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
18. Experience interacting with regulatory authorities, especially the FDA and EMA
19. Ability to speak and interact with a diverse group of individuals on technical and business topics
20. Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
21. Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
22. A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
23. Track record of successful interactions with regulatory and health authorities
24. You are a connector, building relationships and partnering across the organization to achieve the company goals
25. You excel in a fast-paced, results-driven, highly accountable environment
26. You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done
27. You show strong leadership with proven ability to build, motivate and develop a team
28. You resonate with the values of argenx and you are ready to drive the Company Culture
29. 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
30. You’ll work in a successful and rapidly growing biotech company, where we foster a dynamic and supportive work environment.
31. This is a full-time position, you’ll be part of a growing team with plenty of opportunities to make an impact.
32. We offer a competitive salary package that comes with a broad range of benefits.