Senior Regulatory Affairs Executive

Description

Kenvue is currently recruiting for a:

Senior Regulatory Affairs Executive - Northern Cluster

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 Cosmetics, OTC and/or Medical Devices 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.

Key responsibilities include:



* Support regulatory activities for National and European procedures (Decentralised, Mutual Recognition) as appropriate.


* Develop and support regulatory strategies (local and regional) in line with business plan.


* Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met:



* Prepares and compiles regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.


* Sign off of packaging material, leaflets, SmPCs and advertising material to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.


* Ensure Marketing Authorisations are maintained and renewed.


* Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.

Ensures compliance within the department by ensuring:


* Global, EAME and local databases are fully maintained.


* Processes, SOPs and working instructions are adhered to.


* Update relevant local and global databases (e.g Documentum, Aris, GLR, Connect etc.) to track current product information.

Provide regulatory advice and perform due diligence for product acquisitions and distributor agreements with third parties.

Ensures regulatory best practice at all times.

Monitor changes in the regulatory environment and highlight any potential impact.

Represent Regulatory Affairs on cross-functional product/project teams and provides regu...