Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Regulatory Affairs Manager

Locatie:

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

Werklocatie:

Hybride

Wat je gaat doen

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  

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