Regional Regulatory Affairs Specialist

4 weeks ago


High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time

Regulatory Affairs Specialist

  • Manages regulatory functions for designated products across the UK, Ireland, and Malta
  • Prepares and submits regulatory applications, addressing inquiries from Health Authorities
  • Reports to the Associate Director of Regulatory Affairs
  • Operates in a hybrid work environment

About Us

At Kenvue, we are committed to enhancing everyday health through scientific advancements and innovation. Our global team is focused on delivering high-quality products that positively impact the lives of millions.

Your Responsibilities

  • Support the coordination and submission of regulatory applications
  • Gather and organize data pertaining to regulatory requirements
  • Prepare and submit necessary regulatory documentation
  • Oversee the review process by regulatory authorities
  • Plan, prioritize, and monitor projects in alignment with timelines
  • Develop a comprehensive understanding of the regulatory landscape
  • Ensure compliance with local regulations for products
  • Review and authorize promotional materials
  • Initiate and approve product artwork
  • Track the status of applications and provide timely updates
  • Identify opportunities for process enhancements
  • Prepare for regulatory audits and inspections
  • Ensure adherence to compliance standards and implement corrective measures
  • Collaborate with business units to achieve regulatory objectives
  • Establish and uphold compliance with processes and standard operating procedures (SOPs)

Qualifications

Primary Location

Europe/Middle East/Africa-United Kingdom-England

Job Function

Regulatory Compliance



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