argenx
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.
Oncology • Autoimmune diseases • Rare Diseases • Antibody based medicines • Immunotherapy
Senior Manager, Regulatory Affairs - Advertising and Promotion
February 12
argenx
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.
Oncology • Autoimmune diseases • Rare Diseases • Antibody based medicines • Immunotherapy
📋 Description
• Provide strategic, operational and tactical regulatory guidance on promotional communications for commercial products • Serve as a regulatory reviewer on cross-functional argenx Medical, Legal and Regulatory review body • Prepare and submit promotional pieces on form 2253 FDA submissions to OPDP • Review and approve materials to ensure consistency with labeling and compliance with FDA regulations • Ensure accurate and contextual incorporation of US Prescribing Information (USPI) • Maintain collaborative relationships with cross-functional argenx teams • Monitor US regulatory promotional environment
🎯 Requirements
• Bachelor’s degree in scientific or regulatory field; advanced degree preferred (e.g., PharmD, JD or equivalent) • 5+ years of regulatory experience in the pharmaceutical or biotech industry, with a focus on advertising and promotion • Ability to work in Eastern Time Zone required
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