Associate Director, Regulatory Affairs

argenx

1d•$164,000 - $225,500

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. The Associate 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.

Requirements

Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 3-5 years must have been in global leadership roles with a focus on FDA
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
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

Nice To Haves

PhD or PharmD preferred

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
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