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Regulatory Affairs Manager

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time
Senior Regulatory Affairs Executive - Northern Cluster

This role reports to a Regulatory Affairs Manager and is based at High Wycombe (hybrid). At Kenvue, we recognize the significance 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 that you already know and love. Care is our expertise.

In this position, you will be responsible for the management of a number of products within a therapy area for Cosmetics, OTC and/or Medical Devices in the UK, Ireland and Malta. You will develop regulatory strategies, prepare regulatory applications and support maintenance activities within relevant therapy areas.

Key Responsibilities:
  • Develop and implement regulatory strategies (local and regional) in line with business plans.
  • Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met.
  • Prepare and compile regulatory submissions (Marketing Authorisations, Reclassifications etc.), responses to Regulatory Agency (RA) questions and other correspondence in accordance with EU regulations and guidelines.
  • Sign off of packaging material, leaflets, SmPCs and advertising material to ensure regulatory compliance for submissions via Zinc, COCOON, Starfish systems etc.
  • Inform the Regulatory Agency/Department of Health (as appropriate) of product discontinuations and licence cancellations.
  • Ensure compliance within the department by maintaining global, EAME and local databases.
Requirements:
  • Initial experience within the Regulatory Affairs environment supporting OTC or Cosmetics.
  • Ability to work independently to plan, conduct, and manage regulatory submissions and multiple projects to meet department and company objectives.
  • Commercial / strategic awareness, implement regulatory strategy, managing and maintaining Marketing Authorisations.
What We Offer:
  • Paid Company Holidays, Volunteer Time, option to buy and sell holiday
  • Learning & Development Opportunities