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.
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…