Sr. Director EU and Int'l Geo-Expansion

argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies in both early and late clinical-stages of development. Our employees are self-disciplined, hardworking, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they are the cornerstone of argenx.

For the expansion of our regulatory team, argenx is looking for a  Sr Director to support the rapid growth needed for successful commercialization.

Key Accountabilities and Responsibilities:

The person in this role is a key member of the global regulatory leadership team. This role serves as a close business partner and facilitator of regulatory strategies to ensure the minimum time between the initial approval and expansion into other markets. This individual is expected to oversee international regulatory activities for products that have approval in key markets (US/EU/Japan) and are now expanding into new territories (Developed, Emerging, Partner Markets). The individual will be a key advisor and enabler of the regulatory strategy leading successful product launches and commercialization at a regional and country level. This includes  driving entry into new geographic markets and ensuring compliance in these markets with reporting requirements and optimizing lifecycle management. The successful candidate will work cross-functionally to navigate complex regulatory landscapes, enhance market presence, and support patient access to innovative therapies worldwide.

Your primary areas of focus are:

Regulatory Strategy for Geo-expansion

• Lead regulatory strategy considerations and interactions for market expansion, including determining reference approvals and oversight of appropriate dossiers and responses to health authority queries across emerging and established markets.
• Collaborate with ASTs and IDTs to align geo-expansion strategies with commercial and business objectives.
• Monitor global regulatory trends and advise on best practice for geo-expansion.
• Serve as the primary regulatory contact for external partners and internal stakeholders during post-approval interactions related to geographic expansions.
• Collaborate with commercial strategy teams, supply chain, CMC, distribution, and market access colleagues to ensure regulatory strategies are aligned with broader organizational strategies.
• Oversee regulatory affairs vendors involved in filings and help ensure high quality interactions with the agencies.
• Foster and mentor the members of the EU/international regulatory community.
• An important aspect of the role is to work with the Global Head of Regulatory and external vendors to develop and implement infrastructure and process improvements to enhance the efficiency of the Global RA organization with a view to enabling more simultaneous submissions.

Lifecycle Management & Compliance

• Work with global regulatory stakeholders (internal and external) to manage regulatory activities associated with product changes, including variations, renewals, and labelling updates, in alignment with regional requirements.
• Identify and implement process improvements to streamline post-marketing compliance activities.
• Build a close relationship with the GPS team to ensure pharmacovigilance and risk management commitments are fulfilled in all markets.

Stakeholder Engagement

• Partner with global and regional teams, Quality, Clinical, and Commercial, to support geo-expansion initiatives.
• Build and maintain strong relationships with health authorities, external partners, and internal stakeholders to facilitate regulatory approvals.
• Represent the company in external forums, conferences, or regulatory working groups to stay informed of regulatory updates and share insights.

Regulatory Intelligence

• Collaborate with the regulatory intelligence team to continuously assess regulatory requirements and changes in global markets to anticipate challenges and mitigate risks.
• Monitor regulatory approvals, trends, and dynamics in clinical areas of interest to the company, and proactively share regulatory intelligence internally, as appropriate 

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 experience of submissions in emerging markets
• 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 and monitoring of the evolving landscape of regulations and guidelines, and with expertise in post-marketing support
• Affinity with science and ability to interact with scientists and clinicians
• Experience interacting with regulatory authorities
• 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
• Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities, optimizing their effectiveness to enable the timely and quality creation of local submissions
• 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 goals