Director, Regulatory Affairs

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