Senior Regulatory Strategist

7 days ago

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

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a key member of our regulatory team, you will be responsible for developing and implementing regulatory strategies across the EMEA region and globally.

Key Responsibilities
  • Develop and implement global and/or regional regulatory strategies, coordinating regulatory actions and results.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Track the status of applications under regulatory review and provide updates to the regulatory team.
  • Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at regional level.
  • Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  • Participate in the development and implementation of, and maintain compliance with, all applicable processes, SOPs, and working instructions.
  • Ensure that enterprise regulatory systems are accurate and fully maintained.
  • Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with quality function.
  • Monitor the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.).
  • Support trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).
  • Partner with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
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, and/or Medical Devices.
  • Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory requirements.
  • 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.

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