Associate Director/Director, Regulatory > Ghent > Joboolo BE :
Société : Argenx Lieu : Ghent Flanders Site source : Talent BE
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, distribution, and post-approval regulatory activities, among others.Your primary areas of focus are:
Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globallyHelp guide the organization on the appropriate filing strategy, and coordinate across disciplines to ensure timely filingsOversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulatorsWorking with the rest of the argenxregulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requestedProvide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user feesMonitor, interpret, and communicate changes to the global regulatory landscape as requiredServe as the regulatory affairs business partner to local commercialization teamsPartner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisionsServe as the conduit between strategy within the assigned project team and the broader global regulatory and development teamsDesired Skills and Experience:
Minimum 10 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDAPhD or PharmD preferredPrior experience working in rapidly growing pharmaceutical organizations is desirableA thorough understanding of the drug development process with expertise in orphan drugs, along with knowledge of the developing landscape of regulations and guidelines, specifically in United StatesDemonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDAAffinity with science and ability to interact with scientists and cliniciansExperience interacting with regulatory authorities, especially the FDA and EMAAbility to speak and interact with a diverse group of individuals on technical and business topicsFamiliarity with current and emerging regulatory legislation, industry trends, and health care business practices globallyHighly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritizationA clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skillsTrack record of successful interactions with regulatory and health authoritiesYou are a connector, building relationships and partnering across the organization to achieve the company goalsYou excel in a fast-paced, results-driven, highly accountable environmentYou are pragmatic, yet creative and innovative and lead while rolling up your sleeves to get it doneYou show strong leadership with proven ability to build, motivate and develop a teamYou resonate with the values of argenx and you are ready to drive the Company CultureYou 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 goal Argenx GhentFlanders
