Head of Regulatory Affairs EMEA

il y a 1 semaine

Ghent, Flanders, Belgique argenx Temps plein

For the expansion of our EMEA team, argenx is looking for a Head of Regulatory Affairs, EMEA.

argenx
argenx is a fast-growing global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Thanks to colleagues based in Europe, the United States and Japan, we translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines.

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:

  • 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 manner 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, including 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.
  • Strong leadership with proven ability to build, motivate and develop a team of full-time and contingent workers.
  • Resonate with the values of argenx and ready to drive the Company Culture.
  • Combine strategic thinking with the ability to execute, both individually and by leading teams, to achieve operational excellence in the face of challenging goals.
  • 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, 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.

Join argenx
At argenx, we build our culture from the collective power of the team and the knowledge that together, we are better. If you are entrepreneurial, curious and committed to making a difference for patients and thrive on creating solutions for rare autoimmune diseases, then argenx is for you.

#J-18808-Ljbffr

  • Regulatory Affairs Manager

    il y a 2 semaines

    Ghent, Flanders, Belgique Inbiose Temps plein

    We are looking for a Regulatory Affairs Manager to join our Inbiose team in Ghent (Belgium).About Inbiose:Inbiose is a spin-off company from Ghent University specialized in the development of innovative health products through biotechnology, specifically human milk oligosaccharides.We are building towards an international health ingredient company,...

  • Head of CMC RA

    il y a 6 jours

    Ghent, Flanders, Belgique argenx SE Temps plein

    The Head of CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs will lead and manage a team responsible for all aspects of CMC regulatory strategy, planning, and execution across the product lifecycle, including both development and commercial phases. This role plays a critical part in ensuring compliance with global regulatory requirements while...

  • EMEA BIS Operations lead

    il y a 2 semaines

    Ghent, Flanders, Belgique Argenx Temps plein

    EMEA BIS Operations lead - Commercial and MedicalFor the expansion of our Business Information Systems (BIS) team, argenx is looking for an EMEA (Europe, Middle East and Africa) BIS Operations lead - Commercial and Medical. The Lead will be a key member of the BIS Commercial and Medical affairs team and will act as the Digital, Process and Technology...

  • Head of Downstream Processing

    il y a 2 semaines

    Ghent, Flanders, Belgique Those Vegan Cowboys Temps plein

    Are you a protein science buff, with a hankerin’ for the fine art of cheese-makin’? Come to Ghent!The Downstream Processing (DSP) posse at Those Vegan Cowboys is on a mission to corral and purify microbial caseins, to make ‘em shine in the cow-free cheese of future generations. Our team rides hard, refining and understanding these proteins so they’ll...

  • Head of Product

    il y a 2 semaines

    Ghent, Flanders, Belgique Silverfin Temps plein

    Who we are? Silverfin is a cloud first solution that enables accountants to streamline significant parts of their workload and spend more time on value adding activities. Silverfin solves a very real problem: it automates a large chunk of the repetitive tasks that people working in financial services spend their time on and improve communication with...

  • Head of HR

    il y a 7 heures

    Ghent, Flanders, Belgique Motmans & Partners Temps plein

    Datwyler, gelegen te Alken, behoort tot een internationale groep met 25 productievestigingen in 4 continenten en meer dan 8000 medewerkers. Het bedrijf richt zich op hoogwaardige elastomeercomponenten en bekleedt leidende posities in aantrekkelijke wereldwijde markten zoals gezondheidszorg, mobiliteit, olie & gas en food & beverage. De groep voert...

  • head of data

    il y a 8 heures

    Ghent, Flanders, Belgique I-mens Temps plein

    i-mens is een onafhankelijke zorgorganisatie. We zijn er voor iedereen, van jong tot oud. We brengen alle zorg aan huis zodat ieder het eigen leven in handen kan blijven houden. Je kan bij ons terecht voor kraamzorg, poetshulp, thuisverpleging, verzorging en zo veel meer. Met i-mens zijn we altijd op zoek naar enthousiaste medewerkers en gemotiveerde...

  • Head of Data

    il y a 7 heures

    Ghent, Flanders, Belgique I-mens Temps plein

    i-mens is een onafhankelijke zorgorganisatie. We zijn er voor iedereen, van jong tot oud. We brengen alle zorg aan huis zodat ieder het eigen leven in handen kan blijven houden. Je kan bij ons terecht voor kraamzorg, poetshulp, thuisverpleging, verzorging en zo veel meer. Met i-mens zijn we altijd op zoek naar enthousiaste medewerkers en gemotiveerde...

  • Head of PMO

    il y a 2 semaines

    Ghent, Flanders, Belgique Cerba Research Temps plein

    Join Our Team as Head of PMO (Project Management Office).Are you an experienced leader who can build and lead high-performing teams? Do you thrive in dynamic environments and possess a talent for strategic planning and achieving operational excellence? This role offers a unique opportunity to build and lead a new department, collaborate with senior...

  • Head of Partnerships

    il y a 2 semaines

    Ghent, Flanders, Belgique Easyfairs Belgium Temps plein

    Je hebt een passie voor events? Je weet mensen te inspireren? En je bent iemand die er altijd helemaal voor gaat? Kom dan aan boord van het snelgroeiende team van Easyfairs Belgium!Bij Easyfairs geloven we in werken met passie en ondernemerschap! Je krijgt volop de ruimte om initiatief te nemen en je talenten te ontwikkelen. De Easyfairs Academy, ons eigen...

  • Head of IT

    il y a 2 semaines

    Ghent, Flanders, Belgique Foodbag Temps plein

    We zijn op zoek naar een enthousiaste Head of IT & Projects om ons IT team te versterken. Als Head of IT & Projects kom je terecht in het management team van Smartmat en ben je verantwoordelijk voor het ontwikkelen en uitvoeren van de IT-strategie van de organisatie.VerantwoordelijkhedenOntwikkelen en implementeren van de IT-strategie in lijn met de...

  • Head of Project Management

    il y a 2 semaines

    Ghent, Flanders, Belgique TrustBuilder Temps plein

    The Head of Project Management is a critical role that entails overseeing customer experience, project management, and service delivery managers within our organization. Reporting to the Senior Vice President Operations & Services, you will play a pivotal part in ensuring seamless service delivery, maintaining exceptional customer satisfaction, and driving...

  • Head of IT

    il y a 2 semaines

    Ghent, Flanders, Belgique Foodbag Temps plein

    Smartmat NV is een snel groeiende fresh food e-commerce organisatie en is op zoek naar een nieuwe collega! Smartwat? We zijn de onderneming achter sterke merken zoals Foodbag.be (dé Belgische maaltijdbox) en 15gram.be (De grootste kookblog van Vlaanderen).Om onze groei naar een technologie-gedreven werking te ondersteunen en ons team te versterken, zijn we...

  • TrustBuilder - Head of Project Management

    il y a 4 semaines

    Ghent, Flanders, Belgique TrustBuilder Temps plein

    The Head of Project Management is a pivotal position entails overseeing customer experience, project management, and service delivery managers within our organization. Reporting to the Senior Vice President Operations & Services, you will play a critical role in ensuring the seamless delivery of services, maintaining excellent customer satisfaction, and...

  • Head of Product

    il y a 5 jours

    Ghent, Flanders, Belgique Optimile NV Temps plein

    Over onsOptimile ontvouwt de toekomst van mobiliteit met ons innovatieve Software as a Service (SaaS)-platform. Vanuit het hart van Gent breiden we onze voetafdruk uit over zes landen en beheren we meer dan 600.000 publieke laadpalen in Europa. We verzorgden, in 2023, met onze oplossing tot 66K Mwh elektriciteit ter ondersteuning van de elektrificatie van de...

  • Head of Product

    il y a 6 jours

    Ghent, Flanders, Belgique Optimile Temps plein

    Over onsOptimile ontvouwt de toekomst van mobiliteit met ons innovatieve Software as a Service (SaaS)-platform. Vanuit het hart van Gent breiden we onze voetafdruk uit over zes landen en beheren we meer dan 600.000 publieke laadpalen in Europa. We verzorgden, in 2023, met onze oplossing tot 66K Mwh elektriciteit ter ondersteuning van de elektrificatie van...

  • Head of Accounting met bedrijfswagen

    il y a 2 semaines

    Ghent, Flanders, Belgique KONNEKT Temps plein

    Bedrijfsprofiel Voor onze klant, een toonaangevende speler gevestigd in de regio van Gent en actief in de voedingssector, zijn we op zoek naar een Head of Accounting. Met een jaarlijkse omzet van meer dan 130 miljoen euro en een sterke focus op innovatie en duurzaamheid, leveren ze zowel aan nationale als internationale klanten. Werken bij hen betekent...

  • Director, Head of Software

    il y a 2 semaines

    Ghent, Flanders, Belgique Tomra Temps plein

    Company Description TOMRA Food is a multinational organisation and a leading provider of sensor-based sorting, peeling and integrated post-harvest solution for the food industries. Transforming global food production to maximise food safety and minimise food loss by making sure Every Resource Counts, has been our strength for over 50 years.At TOMRA, we want...

  • Head of Digital Programmes

    il y a 2 semaines

    Ghent, Flanders, Belgique Vandemoortele Temps plein

    Share our taste for life!Together with you we want to empower you to achieve this mission with us. We value you as a person and actively support you on your professional journey, while caring for your future. Join our big little family and let’s make products for you and the world to love.Your roleAs the Head of Digital Programmes within our Global Digital...

  • VP Global Sales

    il y a 2 semaines

    Ghent, Flanders, Belgique Wolters Kluwer Temps plein

    Wolters Kluwer is seeking a dynamic and results-oriented VP Global Sales & Relationship Management for FRR OneSumX, our suite of integrated regulatory, financial reporting, and risk management technology solutions focused on the financial services industry. This role is responsible for driving revenue growth through new business acquisition, renewals,...