IE Skin Health Regulatory Affairs Manager

Overview

Kenvue Is Currently Recruiting For a UK/IE Skin Health Regulatory Affairs Manager

UK/IE Skin Health Regulatory Affairs Manager

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. Science is our passion; 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. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you!

Join us in shaping our future–and yours. For more information, .

Role

Reports To:

Sr Dr Northern Europe and Head of S&EH

Location:

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

Work Location:

Hybrid

What You Will Do

Job title:

UK/IE Skin Health Manager Regulatory Affairs

Reporting to:
Director Regulatory Affairs

Functional group: EMEA Regulatory Affairs (R&D)

Location:

Reading, United Kingdom

The Manager Regulatory Affairs is a country expert with an in-depth understanding of the regulatory environment within their geographical area of responsibility as well as requirements and strategies 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
• Creates an environment of operational excellence through regulatory expertise by managing and developing direct reports and collaborating with cross-functional teams to successfully achieve affiliate regulatory objectives
• 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
• Facilitates and cultivates external relationships, representing Kenvue with the relevant regulatory agencies and industry & professional associations as required
• Represents the Regulatory Affairs function as appropriate in Cluster, functional and business Leadership teams

The role requires close cooperation with Commercial/Marketing teams within a cluster.

• Provides 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.
• 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 claims.
• Prepares and submits regulatory submissions according to applicable local 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.

• 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…