Senior Regulatory Affairs Specialist UK/IE - Self Care
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! Regulatory Affairs Manager
Hybrid
The Senior Regulatory Affairs Specialist UK/IE - Self Care has an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements for regulatory submissions, approval pathways and compliance activities and the potential impact of these on business objectives.
~ Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan
~ Manages the coordination, compilation, submission of new drug applications, cosmetics, medical devices, food supplements or any similar product to the regulatory agencies within their geographical and/or brand area of responsibility
~ Maintains compliance for all products with local regulations and quality system requirements
Regulatory Strategy
~ Works independently to provide regulatory input and technical guidance on local regulatory requirements to product development teams
~ Assesses the acceptability of quality, preclinical and clinical documentation for submission filing to comply with applicable local Health Authority requirements, where relevant.
~ 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.
~ Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines.
~ Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.
~ Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at local and regional level.
Regulatory Compliance
Maintains awareness of current regulations and anticipates implications and opportunities as a result of changes to the relevant regulatory environments. Ensures that all products comply with local regulatory and quality system requirements.
Participates in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions
~ Reviews and approves promotional materials for assigned local Kenvue products and assists in claim support
~ Ensures that the enterprise Regulatory systems are accurate and fully maintained
~ Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally
~ Identifies local process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives
~ Supports internal and external audits and inspections in collaboration with quality function
Relevant Bachelor's Degree or higher
~ 6+yrs related regulatory experience
~ Expertise across a broad spectrum of Regulatory classifications including Medicinal Products, Cosmetics, Commodities and/or Medical Devices
Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle. Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance
~ Proficiency in English
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