Senior Regulatory Affairs Specialist

Kenvue
Reading
3 months ago
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About Kenvue

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® you already know and love. Science is our passion; care is our talent.


Senior Regulatory Affairs Specialist (Skin Health & Beauty)

Reports To: Regulatory Affairs Associate Manager
Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire
Work Location: Hybrid


Role Overview

The Senior Regulatory Affairs Specialist is responsible for the development of regulatory strategies across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Skin Health & Beauty franchise.


Responsibilities

  • Evaluate and coordinate regulatory deliverables for cosmetics and/or medical devices within your geographical and/or brand area of responsibility.
  • Develop effective partnerships with R&D, franchise (marketing) and local regulatory colleagues.
  • Assist in the preparation of technical documentation for the registration and maintenance of products throughout their entire lifecycle.
  • Represent the Regulatory Affairs function within the Skin Health & Beauty Franchise.
  • Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and developing technical files to support local review processes.
  • Organize materials from preclinical and clinical studies for review and assist in the review process.
  • Prepare and submit regulatory submissions according to applicable requirements and guidelines.
  • Assist in scheduling meetings with internal stakeholders and regulators, and develop and organize materials for these meetings.
  • Track the status of applications under regulatory review and provide updates to the regulatory team.
  • Familiarize yourself with current regulatory legislation to keep knowledge up‑to‑date at the regional level.
  • Maintain logs of communication and outcomes with regulators and other relevant stakeholders.
  • Maintain awareness of current regulations and anticipate implications and opportunities arising from regulatory changes.
  • Participate in the development, implementation and maintenance of applicable processes, SOPs and working instructions.
  • Ensure that enterprise regulatory systems are accurate and fully maintained.
  • Review and, if necessary, escalated compliance issues and implement appropriate corrective/preventive actions locally.
  • Identify and implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with the quality function.
  • Monitor the regulatory environment (specific regulations, guidance, and other relevant information) and maintain information resources.
  • Support trade associations and working groups, develop impact assessments, influence strategies, and lead solutions at EU and local levels (if relevant).
  • Partner with the business to deliver regulatory outcomes that enable committed business plans within your area of responsibility.
  • Apply strategic direction with independent judgment, executing actions that directly impact operational results.
  • Represent Regulatory Affairs on cross‑functional product/project teams and provide regulatory advice.
  • Use effective communication and influencing skills to grow key relationships with internal and external contacts.
  • Act as delegate for the Senior Manager Skin Health & Beauty / Essential Health as requested.

Requirements and Qualifications

  • Relevant Bachelor's Degree or higher.
  • Expertise across a broad spectrum of regulatory classifications, including cosmetics and commodities.
  • Knowledge of regulatory frameworks and external environments, with the ability to apply these to regulatory solutions throughout the product lifecycle.
  • Solid understanding of regulatory, medical, safety and quality requirements in the markets of relevance.
  • Proficiency in English.
  • Excellent communication skills – articulate and express complex regulatory or technical concepts clearly, both verbally and in writing.
  • Strong interpersonal skills – able to build effective personal networks internally and externally.
  • Highly collaborative with a strong sense of ownership, accountable and rewarded for delivering results.
  • Strong organizational and time‑management skills, able to work under pressure.
  • Demonstrable commercial focus and business acumen to thrive in a fast‑paced, dynamic results‑driven environment.
  • In‑depth knowledge of the business, organizational goals, the Regulatory Affairs function and cross‑functional business partners to inform decisions and execute business strategies.
  • Ability to represent RA function on cross‑functional teams and governance forums.
  • Ability to work effectively in a multi‑cultural, highly matrixed organization.
  • Experience cultivating and leveraging strategic networks and partnerships.
  • Proficiency in English.

Additional Information

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 daily. 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.


Disability accommodation statement

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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