Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Hybrid The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products . Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).
Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations. Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible. Prioritizes, plans and monitors allocated projects against defined timelines Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements Ensures that all assigned products comply with local regulatory and quality system requirements. Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained Identifies & initiates local process improvement opportunities and manage changes as required Assists in the preparation for internal and external audits and inspections in collaboration with others Relevant Bachelor's Degree or higher ~6+yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).~ Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.~ able to build effective personal networks internally and externally.~ Proficiency in English
Competitive Benefit Package· Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!· Learning & Development Opportunities· If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.”, “datePosted”: “2026-05-21”, “hiringOrganization”: { “@type”: “Organization”, “name”: “Kenvue”, “sameAs”: “https://uk.whatjobs.com/pub_api__cpl__438835655__4861?utm_campaign=publisher&utm_medium=api&utm_source=4861” }, “jobLocation”: { “@type”: “Place”, “address”: { “@type”: “PostalAddress”, “addressLocality”: “” } } }
Senior Regulatory Affairs Specialist At Kenvue , 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 – including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. care is our talent.
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Hybrid The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products . Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).
Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations. Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible. Prioritizes, plans and monitors allocated projects against defined timelines Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements Ensures that all assigned products comply with local regulatory and quality system requirements. Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained Identifies & initiates local process improvement opportunities and manage changes as required Assists in the preparation for internal and external audits and inspections in collaboration with others Relevant Bachelor’s Degree or higher ~6+yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).~ Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.~ able to build effective personal networks internally and externally.~ Proficiency in English
Competitive Benefit Package· Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!· Learning & Development Opportunities· If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation….