Regulatory Affairs Associate Director - EU Regulatory Lead - FSP Client Dedicated

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Regulatory Affairs Associate Director - EU Regulatory Lead– Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to lead innovative projects and provide strategic regulatory intelligence that makes a real difference in product development. As a Regulatory Affairs Associate Director, you'll play a key role in guiding product development from preclinical stages through registration and optimization. You will provide regulatory expertise and client interface, offering strategic guidance and updates on country, regional, and global regulatory intelligence. Routinely act as an adviser to other units within the department and liaise with local country regulatory authorities. Responsible for acting as a liaison with internal and external clients in the provision and marketing of these services. For the expansion of our regulatory team, we are looking for an EU Regulatory Lead, to support on of our clients on the rapid growth needed for successful commercialisation. 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, 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 commercialisation. 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. What You’ll Do: • Provide strategic, operational and tactical regulatory insight on pre-approval and post-approval activities • Help guide the organisation 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 • Acts as a global lead in providing review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements. • Acts as lead subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects. Provides internal clients with up-to-date legislation and guidance as it becomes available. • Ensures quality performance for key/managed projects. • Manages project budgeting/forecasting functions. • Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract