Regulatory Affairs Specialist

4 weeks ago

High Wycombe, Buckinghamshire, United Kingdom Fashion Jobs Full time
Job Title: Senior Regulatory Affairs Specialist

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

Key Responsibilities:
  1. Develop and implement 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. Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  5. Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions.
  6. Ensure that the enterprise Regulatory systems are accurate and fully maintained.
  7. Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
  8. Support internal and external audits and inspections in collaboration with quality function.
  9. Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.).
  10. Support in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).
  11. 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 Supplements 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. Competitive Benefit Package.
  2. Paid Company Holidays, Paid Vacation, Volunteer Time & More
  3. Learning & Development Opportunities.

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