Head of Regulatory Affairs EMEA

argenx

Ghent, Belgium

PURPOSE OF THE ROLE

The Head of Regulatory Affairs, EMEA, is a key member of the global regulatory team as well as the EMEA Leadership Team (ELT). This role serves as a close business partner and facilitator of regulatory activities, and is expected to contribute to build and grow the organization across the region. The individual will play a critical role across the product life cycle and will be a key advisor and enabler of successful product launches and commercialization at a regional and country level across the region. In close collaboration with other functional heads 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, distribution, and post-approval regulatory activities, among others.

ROLES AND RESPONSIBILITIES

An important aspect of the role is to work with the Global Head of Regulatory to develop and implement infrastructure and process improvements to enhance the efficiency of the Global RA organization with a view to enabling more simultaneous submissions;
Establish the EMEA regulatory strategy for marketed and pipeline products and ensure it is in line with the global regulatory strategy, taking into account the diverse needs of the EMEA region;
Perform or oversee the preparation of the registration dossiers and adequate response to all agency questions;
Ensure the labelling components relevant to the region are based on the company core datasheet and prepared in conjunction with the EMEA team;
Secure regulatory approvals within the EMEA region, on time as per plan, ensuring cross-functional partners are fully aware of procedures and timelines to guarantee organizational readiness;
Proactively seek out robust cross-functional input to help inform decision-making and appropriate trade-offs regarding labelling, procedural steps, and overall probability of regulatory success;
Collaborate with supply chain, CMC, distribution, and market access colleagues to ensure regulatory strategies are aligned with broader organizational strategies;
Monitor regulatory approvals, trends, and dynamics in clinical areas of interest to the company, and proactively share regulatory intelligence internally, as appropriate;
Provide strategic, operational and tactical regulatory insight on pre-approval activities, including EAP development and roll-out;
Serve as the regulatory affairs business partner to local commercialization teams on all matters related to product promotion and materials review;
Partner with medical, legal, quality, PV, market access and distribution teams to ensure regulatory input is provided in a timely matter to support business decisions;
Ensure alignment between business strategy within the EMEA team and the broader global regulatory strategy and development teams;
Support the EMEA business in all other regulatory-related activities, this includes local regulatory activities in individual member states, where needed;
Oversee regulatory affairs vendors involved in filings and help ensure high quality interactions with the EMA and other EMEA agencies;
Lead and develop the EMEA regulatory team.

SKILLS AND COMPETENCIES

Prior experience in the build-out of organizations and the creation of regulatory infrastructure to support commercialization from scratch;
A thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of and monitoring of the evolving landscape of regulations and guidelines, specifically in Europe, Middle East and Africa;
Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines in Europe, including direct experience leading end-to-end regulatory submissions;
Affinity with science and ability to interact with scientists and clinicians, internally and externally;
Direct experience interacting with regulatory authorities across EMEA, and a successful track record of interactions among regulatory agencies;
A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills in English and at least one other major EU language, to succeed within a multi-cultural and multi-lingual global environment;
Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities, optimizing their effectiveness to enable the timely and quality creation of local submissions;
You show strong leadership with proven ability to build, motivate and develop a team of full time and contingent workers;
You resonate with the values of argenx and you are ready to drive the Company Culture;
You combine strategic thinking with the ability to execute, both individually and by leading teams, to achieve operational excellence in the face of challenging goals;
Is agile and demonstrates adaptability, comfort with ambiguity, trust-building, and resilience;
Demonstrable experience with project management, proactive planning, priority setting, and securing alignment;
Ambitious, inquisitive naturally, a quick study, with demonstrated eagerness to continuously learn, self-improve and develop. This includes being comfortable giving and receiving feedback in a diverse environment;
Passionate and prepared to lead and contribute to our culture, which is driven by our corporate values of co-creation, innovation, empowerment, excellence, and humility.

EDUCATION, EXPERIENCE

Minimum 10 years of regulatory affairs leadership experience within biopharmaceutical organizations, of which at least 5 years must have been in senior leadership roles overseeing European regulatory activities;
PhD or PharmD preferred.

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