Senior Regulatory Affairs Specialist

Company Overview

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®. Science is our passion; care is our talent.

About the Role

Position: Senior Regulatory Affairs SpecialistReports to: Senior CMC ManagerLocation: Europe/Middle East/Africa, United Kingdom, Reading, BerkshireWork Location: Hybrid

Responsibilities

• Prepare and submit regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.
• Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
• Prioritise, plan, and monitor allocated projects against defined timelines.
• Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
• Ensure that all assigned products comply with local regulatory and quality system requirements.
• Assist in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
• Identify and initiate local process improvement opportunities and manage changes as required.
• Assist in the preparation for internal and external audits and inspections in collaboration with others.
• Partner with other critical functions to execute plans to address crises and other sensitive issues.

Qualifications

• Relevant Bachelor’s Degree or higher.
• 6+ years related regulatory experience, ideally with non‑prescription EU procedures (MRP/DCP).
• Good attention to detail.
• 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 rewarded for delivering results.
• Strong organisational 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.

Desired Qualifications

• Knowledge of consumer healthcare environment and product development.
• Understanding of processes and departments within a healthcare company.
• Effective time and organisation management.

Benefits

• Competitive benefit package.
• Paid company holidays, paid vacation, volunteer time, Summer Fridays & more.
• Learning & development opportunities.
• Employee resource groups.

Additional Information

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

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