Director, Regulatory Affairs

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $212k - $291.5k / year

⏰ Full Time

🔴 Lead

🚔 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 • Manage and lead health authority interactions, briefing packages, response documents, and FDA correspondence • 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 development of labeling documents including target product profile, CCDS, and USPI • Provide strategic regulatory input to clinical protocols, clinical and nonclinical reports, and summary documents • Partner with medical, legal, quality, pharmacovigilance, and distribution teams • Serve as Global Regulatory Lead on 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 issues

🎯 Requirements

• Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations • At least 5–7 years in global leadership roles with a focus on FDA • PhD or PharmD preferred • Prior experience working in rapidly growing pharmaceutical organizations is 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 involved in medicine approvals, with a focus on the FDA • Affinity with science and ability to interact with scientists and clinicians • Experience interacting with regulatory authorities • Ability to speak and interact with diverse individuals on technical and business topics • Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally • 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 to shape regulatory strategy • Clear communication and stakeholder influence skills • Outstanding presentation, written, and verbal communication skills • Experience with people management/coaching/mentoring preferred • Strong leadership with ability to build, motivate, and develop a team • Ability to combine strategic thinking with execution in a matrix environment • Ability to work in a fast-paced, results-driven, highly accountable environment • Ability to build relationships and partner across the organization • Alignment with argenx values and company culture

🏖️ Benefits

• Short-term incentive programs • Long-term incentive programs • Retirement savings plans • Health benefits • Comprehensive benefits package • Equal consideration for employment without discrimination • Reasonable accommodation in completing the application, interviewing, or participating in the candidate selection process