Regulatory Affairs Associate

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 Associate

The Regulatory Affairs Associate oversees a range of regulatory activities for 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.

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 organizes 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.

· 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

· Assists in the maintenance of compliance for all products with local regulations and quality system requirements

· 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 · 2+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

· Proficiency in English

· Excellent oral and written communicator

· Able to work under pressure and to tight time deadlines

· Able to work under own Initiative

· Analytical thinker

· Computer literate

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

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