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. For the expansion of our regulatory team, argenx is looking for a Director Regulatory Affairs, argenx US, to support the rapid growth needed for successful commercialization. The role will report into the US Head of Regulatory Affairs.
Roles and Responsibilities: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.Your primary areas of focus are:
- 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
- Lead and/or participate in meetings with the FDA as appropriate and prepare company personnel for interactions 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 and negotiation strategies
- Provide input into strategy with respect to clinical study design
- Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions
- 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
- A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
- 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
#LI-RemoteAt 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.If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at ...@argenx.com. Only inquiries related to an accommodation request will receive a response.