Global Regulatory Lead - United States, Part Time

OverviewAs a Global Regulatory Lead you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.ResponsibilitiesProvide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activitiesgloballyHelp 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 argenx regulatory 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 teamsQualificationsMinimum 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 preferred Prior 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 clinicians Experience interacting with regulatory authorities, especially the FDA and EMAWhat ICON can offer you:Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:Various annual leave entitlementsA range of health insurance offerings to suit you and your family's needsCompetitive retirement planning offerings to maximise savings and plan with confidence for the years aheadGlobal Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-beingLife assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among othersVisit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Apply tot his job Apply To this Job