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Regulatory Affairs Specialist

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time
Job Summary

**Senior Regulatory Affairs Specialist – Self Care**

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our consumer products in the UK, Ireland, and Malta.

Key Responsibilities
  • Partner with our business teams to deliver regulatory outcomes that enable our business plans.
  • Coordinate and submit regulatory applications to the relevant authorities in the UK, Ireland, and Malta.
  • Prepare and submit regulatory applications according to applicable regulatory requirements and guidelines.
  • Advise on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
  • Prioritize, plan, and monitor allocated projects against defined timelines.
  • Monitor the progress of regulatory authority assessments through effective communication.
  • Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
  • Participate in trade association working groups and support the development of impact assessments, influencing strategies, and leading solutions.
  • Ensure all assigned products comply with local regulatory and quality system requirements.
  • Monitor progress of applications against set timelines and act to minimize delays and anticipate potential risks.
  • Review and approve promotional materials for assigned local Kenvue products.
  • Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  • Ensure that our enterprise regulatory systems are accurate and fully maintained.
  • Track the status of applications under regulatory review and provide updates to the wider Kenvue teams.
  • Support the identification and initiation of local process improvement opportunities and manage changes as required.
  • Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
  • Monitor the regulatory environment and identify relevant regulatory initiatives.
Requirements
  • Relevant Bachelor's Degree or higher.
  • At least 5 years of relevant working experience.
  • Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement, Cosmetics, and/or Medical Devices.
  • Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
  • Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  • Leadership and coaching skills with experience of people development.
  • Proficiency in English.