Senior Regulatory Affairs Specialist

<span id="requisitionDescriptionInterface.reqTitleLinkAction.row1" title="">Senior Regulatory Affairs Specialist</span><span id="requisitionDescriptionInterface.ID1326.row1" title="">-</span><span id="requisitionDescriptionInterface.reqContestNumberValue.row1" title="">2507030367W</span><p></p><h2 xmlns:ftl="http://www.taleo.net/ftl" xmlns:htm="http://www.w3.org/1999/xhtml" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"><span>Description</span></h2><span><span> </span></span><span id="requisitionDescriptionInterface.ID1388.row1" title=""><p><span lang="EN-US">Kenvue is currently recruiting for: </span></p> <p><b><span lang="EN-US">Senior Regulatory Affairs Specialist</span></b><b><span lang="EN-US"></span></b></p> <p><span lang="EN-US">This position reports to Regulatory Affairs Manager and is based at our Søborg office.</span></p> <p><b><span lang="EN-US">Who we are</span></b></p> <p><span lang="EN-US">At <span><span><span> </span></span></span></span><span lang="EN-US"><a href="http://kenvue.com/careers"><span>Kenvue</span></a></span><span lang="EN-US">, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands —</span><span lang="EN-US"> </span><span lang="EN-US">including OTC brands such as NICORETTE®, IPREN®, LIVOSTIN®, IMODIUM®, PEPCID® and consumer health brands like NEUTROGENA®, </span><span><span lang="EN-US">LISTERINE®, NATUSAN®, PIZ BUIN® and o.b. ®. Our employees share a digital-first mindset, an</span></span><span lang="EN-US"> approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes. </span></p> <p><span lang="EN-US">The Kenvue site in Helsingborg, Sweden is the home of the strong and growing brand NICORETTE®, a global market leader in smoking cessation. In 2021 our production facility was recognized as a Lighthouse by World Economic Forum, marking us as a beacon in The Fourth Industrial Revolution.</span></p> <p><span lang="EN-US">The Helsingborg site is one of the largest employers in the city of Helsingborg, and the business is divided in two separate departments: Operations, where we house our manufacturing activities and R &amp; D, our global development center for excellence working in three therapeutic areas for selfcare treatments: Smoking Cessation, Digestive Health and Cough &amp; Cold. For more information</span><span><span lang="EN-US">, </span></span><span lang="EN-US"><a href="https://www.youtube.com/watch?v=XhsbOsBiX_M"><span>click here</span></a></span><span><span lang="EN-US"></span></span></p> <p><span lang="EN-US"><span></span></span></p> <p><b><span lang="EN-US">What you will do</span></b><span lang="EN-US"><span>  </span></span></p> <p><span lang="EN-US">The Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance and securing approvals for new products, line extensions, and additional claims, all while supporting business objectives. They manage the coordination and submission of regulatory applications for drugs, cosmetics, medical devices, and similar products, ensuring a smooth approval process with regulatory agencies.</span></p> <p><span lang="EN-US">Beyond submissions, they play a crucial role in maintaining compliance with local regulations and quality system standards, ensuring all products meet the necessary legal and industry requirements.</span><span lang="EN-US"></span></p> <p><span lang="EN-US"></span></p> <p><u><span lang="EN-US">Key Responsibilities</span></u><b><span lang="EN-US"> </span></b></p> <p><b><span lang="EN-US">Regulatory Strategy </span></b><span lang="EN-US"></span></p> <ul> <li><span lang="EN-US">Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams</span></li> <li><span lang="EN-US">Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.</span></li> <li><span lang="EN-US">Provides regulatory assessment and guidance for proposed product claims/labeling, ensuring that the provided clinical and non clinical data are consistent with the local regulatory requirements and support the proposed product classification and claims.</span></li> <li><span lang="EN-US">Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.</span></li> <li><span lang="EN-US">Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.</span><span lang="EN-US"> <span></span></span></li> <li><span lang="EN-US">Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.</span></li> </ul> <p><b><span lang="EN-US">Regulatory Compliance</span></b><span lang="EN-US"></span></