Regulatory Affairs Specialist

3 days ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Inc Full time
Job Description

Senior Regulatory Affairs Specialist

Kenvue Inc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. 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 Global and Regional Regulatory Strategies: Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results and develops global/regional dossiers to support local review processes.
  2. Prepare and Submit Regulatory Submissions: Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  3. Track Regulatory Status: Track the status of applications under regulatory review and provides updates to the regulatory team.
  4. Stay Up-to-Date with Regulatory Legislation: Familiarizes and understands the current regulatory legislation to keep the legislative knowledge up to date at regional level.
  5. Monitor Regulatory Environment: Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to the relevant regulatory environments.
  6. Compliance and Audits: Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions. Ensure that the 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.
  7. Regulatory Partnerships: Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.). Supports in trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).
  8. Business Partnerships: Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
  9. Leadership and Coaching: Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.

Requirements:

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

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