Senior Regulatory Affairs Specialist

Description

Kenvue is currently recruiting for a:

Senior Regulatory Affairs Specialist

This position reports into a Regulatory Affairs Manager is based at High Wycombe (hybrid)

Who We Are

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 made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of 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.

What You Will Do

In this role, you will be responsible for the management of a number of products within a therapy area for OTC in the UK, Ireland and Malta.

You will look into the development of regulatory strategies, preparation of regulatory applications and support maintenance activities within relevant therapy area.


* 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

Key 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.

Commun...