Global Regulatory Lead

argenx

109d

About The Position

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 and cancer. 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.

Requirements

• 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.
• Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA.
• Affinity with science and ability to interact with scientists and clinicians.
• 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.

Nice To Haves

• 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.

Responsibilities

• Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally.
• Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings.
• Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators.
• Provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requested.
• Provide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user fees.
• Monitor, interpret, and communicate changes to the global regulatory landscape as required.
• Serve as the regulatory affairs business partner to local commercialization teams.
• Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions.
• Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams.

What This Job Offers

• Number of Employees: 1,001-5,000 employees