Sr. Director Asset Regulatory Affairs 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. 

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 Senior Director to support the rapid growth needed for its pipeline.

Preferred locations: Belgium, Switzerland, East Coast US

Key Accountabilities and Responsibilities:

The person in this role is a key member of the global regulatory leadership team and will be working on a late stage asset that is a pipeline in a product and preparing for its first global marketing application. The role provides a critical contribution to the development of product regulatory strategies for different indications and will be a key advisor and enabler of successful product launches and commercialization activities. This role serves as a close business partner and facilitator of regulatory activities across a portfolio of indications, and is expected to contribute to developing sound regulatory strategies globally. 

This role can be based remotely either near Boston, Belgium or Switzerland.

Your primary areas of focus are:

Regulatory Strategy for Asset Team

• Provide strategic, operational and tactical regulatory insight on global activities for assigned programs with focus on innovative ways of addressing barriers to development strategies as well as speeding the availability of our products to patients

• Work with the rest of the argenx regulatory team, provide strategic regulatory guidance for assigned compound, help guide the organization on the appropriate filing strategy in primary regions, and coordinate across disciplines to ensure timely filings as applicable

• Articulate global regulatory strategy to Sr. Management   

• Partner across all functions of the asset teams to ensure regulatory input is provided in a timely matter to support business decisions  

• Ensure coordinated regulatory strategy across the regulatory leads on the indication development teams, the asset team and the broader global regulatory team

• Collaborate with asset teams, IDTs and PMO/Reg PM staff to plan the global submission timeline for the asset and project resourcing requirements and to ensure regulatory strategies are aligned with broader organizational strategies

• Oversee and mentor the members of the regulatory community

Stakeholder Engagement

• 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 and organizationally with Regulatory Policy to continuously assess regulatory requirements and changes in global markets to anticipate challenges and mitigate risks.

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 driving and implementing sound regulatory strategies leading to successful submissions and launches.  

• PhD or PharmD preferred.

• Experience in the development of therapeutics for autoimmune neurology, renal or rheumatology conditions is preferred

• Prior experience working in rapidly growing pharmaceutical organizations is desirable

• A thorough understanding and experience with the development and licensure of biologic drugs for orphan and pediatric indications along with knowledge of and monitoring of the evolving landscape of regulations and guidelines

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

• A strong scientific background and ability to interact with scientists and clinicians

• 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 

• 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

• 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, to achieve operational excellence in the face of challenging goal

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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