Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

Regulatory Affairs Manager

Местонахождение:

Europe/Middle East/Africa, United Kingdom, Reading, Berkshire

Место работы:

Гибрид

Что ты будешь делать

The Senior Regulatory Affairs Specialist 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 

The Roles & Responsibilities include: 

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. Communicates changes to appropriate management and cross functional experts as appropriate and implements locally 

• 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  

• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. 

• 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 

Specific requirements

• 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  

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.