Associate Director, Regulatory Affairs

🕒 September 22

🇺🇸 United States – Remote

💵 $164k - $225.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• Develop and implement robust US regulatory strategy for assigned projects • Provide strategic, operational, and tactical regulatory input on pre-approval and post-approval activities focused on the US • Lead and facilitate activities related to regional strategy • Serve as primary contact with the FDA • Lead or participate in FDA meetings and prepare company personnel for FDA interactions • Lead and oversee preparation of dossier content for INDs, BLAs, and NDAs • Critically review submission documents for regulatory compliance • Ensure timely, strategy-aligned responses to FDA questions • Participate in labeling document development and negotiation strategies • Provide input into clinical study design strategy • Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input for business decisions • Monitor, interpret, and communicate changes to the US regulatory landscape • Monitor competitive landscape, including regulatory precedents, labeling differences, and therapeutic-area issues • Contribute to global regulatory strategies across the product life cycle • Advise and enable product launches and commercialization

🎯 Requirements

• Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations • At least 3–5 years in global leadership roles with a focus on FDA • PhD or PharmD preferred • Prior experience in rapidly growing pharmaceutical organizations desirable • Thorough understanding of the drug development process • Expertise in orphan drugs • Knowledge of the developing landscape of regulations and guidelines globally • Demonstrated ability to coordinate critical regulatory documents for medicine approvals, focused on FDA • Affinity with science and ability to interact with scientists and clinicians • Experience interacting with regulatory authorities required • Ability to speak and interact with diverse individuals on technical and business topics • Familiarity with current and emerging regulatory legislation, industry trends, and global health care business practices • Highly developed organizational and project management skills • Strategic planning, delegation, resource allocation, and workload prioritization skills • Understanding of digital technologies and AI-enabled environments • Ability to leverage data-driven insights and innovative tools • Clear written, verbal, and presentation communication skills • Ability to build relationships and partner across the organization • Ability to work in a fast-paced, results-driven, highly accountable environment • Pragmatic, creative, and innovative approach • Strong leadership and ability to build, motivate, and develop a team • Alignment with argenx values and company culture • Strategic thinking and ability to execute individually and by leading teams in a matrix environment

🏖️ Benefits

• Short-term incentive programs • Long-term incentive programs • Retirement savings plans • Health benefits • Other benefits subject to applicable plans and program guidelines • Equal consideration in an inclusive, non-discriminatory environment • Reasonable accommodation in the application and selection process

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