The Director Regulatory Affairs is a key member of the global regulatory team. 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 will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others.

Roles & Responsibilities:

·       Responsible for the development and implementation of robust US regulatory strategy for assigned projects

·       Provide strategic, operational and tactical regulatory input on pre-approval and post-approval activities with a focus on the US and lead/facilitate activities related to regional strategy

·       Serve as the primary contact with the FDA

·       Manage and lead all HA interactions, preparation of briefing packages, response documents, and correspondence with FDA

·       Lead and oversee the preparation of dossier content for INDs, BLAs/NDAs

·       Perform critical review of submission documents to ensure compliance with regulatory requirements

·       Ensure that responses to FDA questions are handled in a timely manner and in line with the approved product strategy

·       Participate in development of labeling documents including target product profile, CCDS and USPI

- Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.

·       Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions

·       May serve as Global Regulatory Lead projects as needed

·       Monitor, interpret, and communicate changes to the US regulatory landscape

·       Monitor the competitive landscape including regulatory precedents, labeling differences and therapeutic area specific issues

Desired Skills and Experience:

·       Minimum 10 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 FDA

·       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 globally

·       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 is required

·       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

- Understanding of digital technologies and AI-enabled environments, leveraging data-driven insights and innovative tools to shape regulatory strategy, drive cross-functional alignment, and support global business objectives

- A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills

- Experience with people management/coaching/mentoring is preferred

- 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

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For applicants in the United States: The annual base salary hiring range for this position is $212,000.00 - $291,500.00 USD. This range reflects our good faith estimate at the time of posting. Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity. This means actual pay may differ from the posted range when justified by these factors. Because market conditions evolve, pay ranges are reviewed regularly and may be adjusted to remain aligned with external benchmarks.

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies. It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.