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:

Senior Manager. Regulatory Affairs, Regional Skin Health.

Местонахождение:

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

Место работы:

Гибрид

Что ты будешь делать

Job Description 

Job purpose 

 

The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Skin Health & Beauty franchise.  

 

• Evaluates and coordinates the regulatory deliverables for cosmetic &/or medical devices, within their geographical and/or brand area of responsibility 

• Develops effective partnerships with R&D, Franchise (Marketing) and local regulatory colleagues.   

• Assists in the preparation of technical documentation for the registration and maintenance of products throughout their whole lifecycle 

• Represents the Regulatory Affairs function as appropriate within the Skin Health & Beauty Franchise. 

 

Essential duties and responsibilities 

 

The Roles & Responsibilities include: 

Regulatory Strategy  

• Works with local and regional regulatory colleagues to develop global and/or regional regulatory 

strategies, coordinating regulatory actions and results and develops global/regional technical files to 

support local review processes. 

• Organizes materials from preclinical and clinical studies for review and assists in the review process. 

• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines, as required. 

• Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings.  

• Tracks the status of applications under regulatory review and provides updates to the regulatory team  

• Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level. 

Regulatory Compliance  

• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders. 

• Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.  

• Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions  

• 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 

• Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives  

• Support internal and external audits and inspections in collaboration with quality function  

Regulatory Advocacy 

• Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.) and maintains information resources. 

• Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).  

 

Specific requirements 

 

• Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.  

• Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit. 

Other features of the job 

 

• Represents Regulatory Affairs on cross-functional product/project teams and provides regulatory advice.  

• Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts. 

Back up activities 

 

Represent the Senior Manager Skin Health & Beauty as delegate on request 

Job Requirements 

Essential knowledge and skills: 

 

• Relevant Bachelor's Degree or higher   

• Expertise across a broad spectrum of Regulatory classifications including Cosmetics & Commodities  

• 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  

Core competencies  

• Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues.  

• Strong interpersonal skills; able to build effective personal networks internally and externally. 

• Highly collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results. 

• Strong organizational and time management skills with an ability to work under pressure. 

• Demonstrable commercial focus and business acumen which will enable him/her to thrive in a fast-paced, dynamic, 

Results-driven environment. 

• In-depth knowledge of the business, organizational goals, Regulatory Affairs function, and cross functional business partners to make informed business decisions and create and execute business strategies. Ability to represent RA function on cross-functional teams and governance forums.   

• Able to work effectively in a multi-cultural, highly matrixed organization 

• Experience in cultivating and leveraging strategic networks and partnerships  

• 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.