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Regulatory Affairs Specialist

2 months ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Full time
Senior Regulatory Affairs Specialist

Join Kenvue, a leading company in the science and healthcare industry, as a Senior Regulatory Affairs Specialist. In this role, you will be responsible for developing and implementing regulatory strategies, preparing regulatory applications, and ensuring compliance with local regulations and quality system requirements.

Key Responsibilities:
  • Develop and implement regulatory strategies to ensure the success of new product registrations, line extensions, and new indications and claims.
  • Manage the coordination, compilation, and submission of regulatory applications to regulatory agencies within your geographical and/or brand area of responsibility.
  • Maintain compliance for all products with local regulations and quality system requirements.
  • Provide regulatory input and technical guidance on local regulatory requirements to product development teams.
  • Assess the acceptability of quality, preclinical, and clinical documentation for submission filing to comply with applicable local Health Authority requirements.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority.
Requirements:
  • 6+ years of experience within the Regulatory Affairs environment supporting OTC.
  • Relevant Bachelor's Degree or higher.
  • Excellent business partnering, analytical, and communication skills.
  • Expertise across Regulatory classifications including Medicinal Products, Cosmetics, Commodities, and/or Medical Devices.
  • Knowledge of regulatory frameworks and external environments.
  • Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  • Proficiency in English.
What We Offer:
  • Paid Company Holidays, Volunteer Time, option to buy and sell holiday.