EU Regulatory Lead Director

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November 1

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argenx

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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.

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

📋 Description

• Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities • Help guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filings with EMA / applicable agencies of the EMEA region • Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulators • Working with the rest of the argenx regulatory team, provide hands-on contributions to regulatory filings, and other areas as requested • Provide regulatory leadership with post-approval activities • Monitor, interpret, and communicate changes to the global regulatory landscape • Serve as the regulatory affairs business partner to local commercialization teams • Partner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions • Serve as the conduit between strategy within the assigned project team and the broader global regulatory and development teams

🎯 Requirements

• Minimum 10 years’ experience in regulatory affairs within pharmaceutical organizations, with a strong emphasis on EMA regulatory frameworks. • Must include at least one end-to-end regulatory submission process, preferably with the centralized procedure • Advanced degree required; PhD or PharmD strongly preferred • Prior experience working in rapidly growing pharmaceutical organizations is advantageous • A thorough understanding of the drug development lifecycle with demonstrated expertise in orphan drug development, along with knowledge of the evolving global regulatory landscape, particularly across Europe and other territories (e.g. Switzerland, UK...etc.) • Demonstrated ability to lead and coordinate the development of critical regulatory documents essential for the approval and life cycle management of medicinal products, with a focus on EU regulatory strategy, including Pediatric Investigation Plans (PIPs) and other key submission components • Established track record of successful engagement with regulatory and health authorities, including preparation for and participation in regulatory interactions.

🏖️ Benefits

• inclusive environment • equal consideration for employment without discrimination