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Regulatory Affairs Specialist

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

About the Role

We are seeking a highly skilled 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 with the Health Authority.
  • 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 at a local level.
  • Ensure all assigned products comply with local regulatory and quality system requirements.
  • Monitor 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 maintain information resources.
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
  • Participate in the development and implementation of, and maintain compliance with, all applicable processes, SOPs, and working instructions.
  • Identify and/or implement local/regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with relevant functions.
  • Provide technical and leadership development as appropriate.

Requirements

To be successful in this role, you will need to have a strong understanding of regulatory requirements and guidelines in the UK, Ireland, and Malta. You will also need to have excellent communication and project management skills, as well as the ability to work effectively in a team environment.