Submission for the position: Senior Regulatory Affairs Executive - (Job Number: 2407025873W)
Kenvue is currently recruiting for a:
Senior Regulatory Affairs Executive - Northern Cluster
This position reports into a Regulatory Affairs Manager and 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 up of 22,000 diverse and brilliant people, 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 the lives 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 the 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 the business plan.
* Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met:
o Prepare and compile regulatory submissions (Marketing Authorisations, Reclassifications, etc.), responses to Regulatory Agency (RA) questions, and other correspondence in accordance with EU regulations and guidelines.
o Sign off on packaging material, leaflets, SmPCs, and advertising material to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems, etc.
o Ensure Marketing Authorisations are maintained and renewed.
o Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
* Ensure compliance within the department by ensuring:
o Global, EAME, and local databases are fully maintained.
o Processes, SOPs, and working instructions are adhered to.
o 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.
* Ensure 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 provide regulatory advice (as appropriate).
* Interact with the Regulatory Agency.
* Provide regulatory guidance to internal stakeholders to allow them to make key decisions on business-critical activities and project feasibility.
* Represent J&J and provide regulatory advice at joint Company/Trade Association initiatives, Regulatory Agency meetings, etc. (as appropriate).
What We Are Looking For
The successful individual will have excellent business partnering, analytical, and communication skills.
You will have initial experience within the Regulatory Affairs environment supporting OTC or Cosmetics and be able to demonstrate the following:
* Life sciences or chemistry graduate to honours level or equivalent.
* Works independently to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
* Work with minimal supervision to determine and develop approaches to solutions with technical guidance on a variety of problems of moderate scope and complexity.
* May mentor Regulatory Executives and provide day-to-day support.
* Project management, understanding of the regulatory environment, interaction with the Regulatory Authorities, commercial/strategic awareness, implementation of regulatory strategy, managing and maintaining Marketing Authorisations.
* Ability to shape plans and connect with the wider organization.
* Deliver on key KPI commitments.
What’s in It for You
* Competitive Benefit Package
* Paid Company Holidays, Volunteer Time, option to buy and sell holiday
* Learning & Development Opportunities
* Employee Resource Groups
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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