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Senior regulatory affairs specialist

Reading (Berkshire)
Permanent
Kenvue
Regulatory affairs specialist
Posted: 8 December
Offer description

Senior Regulatory Affairs Specialist

Location: Reading

Duration: 6 months initially

Working mode: Hybrid

Hours: Full-time, 37 hours per week

Pay rate range: Competitive hourly rate (role inside IR35, PAYE and Umbrella pay type options available)

Join Kenvue, the home of iconic health and wellness brands like NEUTROGENA®, AVEENO®, and LISTERINE®. We are seeking an experienced and dedicated Senior Regulatory Affairs Specialist to provide essential regulatory expertise across our diverse product portfolio.

You will be the local regulatory expert, ensuring our products comply with UK/EU regulations and influencing business objectives through expert guidance on submissions, approvals, and ongoing compliance.


Roles and Responsibilities

* Regulatory Strategy & Submissions
o Work independently to provide critical regulatory input and technical guidance to cross‑functional product development teams.
o Conduct comprehensive regulatory assessments of quality, preclinical, and clinical documentation for submission filing, ensuring full compliance with local Health Authority requirements.
o Drive and prepare regulatory submissions (e.g., cosmetic notifications, medicinal product applications) in accordance with applicable guidelines.
o Provide expert regulatory assessment and guidance on proposed product claims and labelling, ensuring alignment with clinical/non‑clinical data and local regulatory requirements.
o Monitor and manage the regulatory authority review process, serving as the key point of communication with the Health Authority.
* Compliance & Legislative Expertise
o Maintain and deepen knowledge of current UK/EU regulatory legislation, proactively anticipating the implications and opportunities of regulatory changes.
o Communicate legislative updates and their impact to management and cross‑functional teams, driving necessary local implementation.
o Ensure all commercialised products strictly comply with local regulatory and quality system requirements.
o Participate in the development and maintenance of applicable internal Processes, SOPs, and working instructions.


What You'll Need to Succeed (Must‑Haves)

* Education: Relevant Bachelor’s Degree or higher (e.g., Science, Pharmacy, or equivalent).
* Experience: 6+ years of progressive, hands‑on regulatory affairs experience.
* Regulatory Expertise: Proven expertise across a broad spectrum of regulatory classifications, including Cosmetics (UK/EU essential), and/or Medicinal Products, Medical Devices, and Commodities.


Core Competencies

* In‑depth knowledge of UK/EU Cosmetic Regulation and compliance.
* Strong background in labelling compliance (UK/EU) and regulatory review of marketing materials.
* Experience in claims development/substantiation and review for regulatory compliance.
* Skills: Solid understanding of regulatory, medical, safety, and quality requirements in relevant markets.
* Language: Fluency/Proficiency in English.


The Ideal Candidate May Also Have (Preferred)

* Experience in the Hair Care segment.
* Knowledge of Study Design relevant to claims substantiation.
* Experience with Clearcast submission processes.
* Familiarity with regulatory review of Social Media and Influencer content.

This role offers a very competitive hourly rate. This contract will initially run for 6 months.

You are welcome here

Kenvue is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

About Kenvue

At Kenvue, we realise 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

We are looking to process the first round of applications within the next 2 working days.

Diversity, Equity & Inclusion

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

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