EU Regulatory Lead Director

EU Regulatory Lead Director

argenx

Ghent, Belgium or Remote, Switzerland

For the expansion of our regulatory team, argenx is looking for an EU Regulatory Lead Director, to support the rapid growth needed for successful commercialization. The role will report into the Head of Regulatory Affairs for Europe and New Territories. This role with cover primarily the EU and will require involvement in the other territories (e.g. UK, Switzerland, Israel and the Middle East...etc.).

The EU Regulatory Lead Director, is a key member of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this role is responsible for high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, and post-approval regulatory activities, among others.

Roles and Responsibilities:

• 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.

Skills and Competencies:

• Affinity with science and ability to interact with scientists and clinicians;
• Ability to speak and interact with a diverse group of individuals on technical and business topics;
• Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally;
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization;
• A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills;
• You excel in a fast-paced, results-driven, highly accountable environment;
• You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done;
• You show strong leadership with proven ability to build, motivate and develop a team;
• You resonate with the values of argenx and you are ready to embrace the Company Culture;
• You combine strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goals.

Education, Experience and Qualifications:

• 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.