Regulatory Affairs Specialist

1 month ago


High Wycombe, Buckinghamshire, United Kingdom Kenvue Inc Full time

Join Kenvue Inc, a leading company in the science and care industry, as a Regulatory Affairs Specialist - EMEA. In this role, you will be responsible for developing regulatory strategies across the EMEA region and globally, providing regulatory input and technical guidance to product development teams within the Self Care franchise.

Key Responsibilities:

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

Requirements:

  1. Relevant Bachelor's Degree or higher.
  2. At least 5 years of relevant working experience.
  3. Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices.
  4. Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
  5. Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  6. Leadership and coaching skills with experience of people development.
  7. Proficiency in English.

What We Offer:

  1. Paid Company Holidays, Paid Vacation, Volunteer Time & More
  2. Learning & Development Opportunities.


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