Regulatory Affairs Specialist

What we do

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.

Who We Are

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, click here.

Role reports to:

Regulatory Affairs Associate Manager

Location:

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

Work Location:

Hybrid

What you will do

Regulatory Affairs Specialist

Job purpose 

 The Regulatory Affairs Specialist is accountable for all regulatory activities associated with their assigned medicines, medical devices, cosmetics and/or food supplement consumer products within their geographical and/or brand area of responsibility. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. 

 

Essential duties and responsibilities 

 The Roles & Responsibilities include: 

Regulatory Strategy  

• Assists in 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 

• Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations. 

• 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, seeking opportunities to expedite regulatory approvals where possible.  

• Prioritizes, plans and monitors allocated projects against defined timelines 

• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements  

Regulatory Compliance  

• Ensures that all assigned products comply with local regulatory and quality system requirements. 

• Reviews and approves promotional materials for assigned local Kenvue products. 

• Initiates, reviews and approves new or revised product artworks in collaboration with Cluster Artwork Coordinator. 

• Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained  

• Identifies & initiates local process improvement opportunities and manage changes as required  

• Assists in the preparation for internal and external audits and inspections in collaboration with others 

 

Specific requirements 

• Relevant Bachelor's Degree or higher   

• 4+yrs related regulatory experience   

 

Job Requirements 

Essential knowledge and skills: 

• Knowledge of consumer healthcare environment and product development 

• Understanding of processes and departments within a healthcare company 

• Effective time and organisation management 

 

Core competencies  

• Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.  

• Good interpersonal skills; able to build effective personal networks internally and externally. 

• Collaborative with a strong sense of ownership, willing to be held accountable and be rewarded for delivering results. 

• Strong organizational and time management skills with an ability to work under pressure. 

• Able to work effectively in a multi-cultural, highly matrixed organization 

• Proficiency in English  

 

 

 

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.