EU Regulatory Lead Director

Join argenx as EU Regulatory Lead Director and support the rapid growth needed for successful commercialization. The role will cover primarily the EU and require involvement in other territories. Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities.

Requirements

• 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

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance