Regulatory Affairs Manager

6 days ago

High Wycombe, Buckinghamshire, United Kingdom Kenvue Inc Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Kenvue Inc. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the success of our new product development, line extensions, and new claims in alignment with our business plan.

Key Responsibilities
  1. Regulatory Strategy:
    1. Provide strategic regulatory input and technical guidance on global and/or regional regulatory requirements to product development teams.
    2. Support business initiatives by strengthening propositions, influencing, and acting as a strategic advisor on brand/need state portfolio forums.
    3. Provide regulatory risk-based assessment and guidance for proposed product claims/labeling, ensuring that provided clinical and non-clinical data are consistent with required regulatory requirements.
    4. Participate in cross-functional project teams to define RA resources, development program requirements, and risks.
    5. Prepare and submit regulatory documentation according to applicable regulatory requirements and guidelines.
    6. Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at regional level.
  2. Regulatory Compliance:
    1. Maintain awareness of current regulations and anticipate implications and opportunities as a result of changes to relevant regulatory environments.
    2. Communicate changes to appropriate management and cross-functional experts as appropriate.
    3. Ensure that all products comply with local regulatory and quality system requirements.
    4. Ensure quality and compliance in all actions.
    5. Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs, and working instructions.
    6. Ensure that enterprise Regulatory systems are accurate and fully maintained.
    7. Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
    8. Manage and support internal and external audits and inspections in collaboration with quality function.
    9. Support crisis management/PR matters as related to regulatory affairs.
  3. Regulatory Advocacy:
    1. Monitor the regulatory environment and provide assessments of the impact of new and changing regulations on the company's areas of interest.
  4. Team Management:
    1. Provide technical and leadership development & coaching to build high-performing team.
    2. Evaluate deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
Requirements
  1. Relevant Bachelor's Degree or higher.
  2. Expertise across a broad spectrum of Regulatory classifications including Cosmetics, Commodities, and/or Medical Devices.
  3. Knowledge of regulatory frameworks and external environments, and the ability to apply these to regulatory solutions throughout the product lifecycle.
  4. Solid understanding of regulatory/medical/safety/quality requirements in the markets of relevance.
  5. Leadership and coaching skills with experience of people development.
  6. Proficiency in English.
  7. Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing.
  8. Strong organizational, people, and time management skills with an ability to work under pressure.
  9. Demonstrable commercial focus and business acumen.
What's in it for you
  1. Paid Company Holidays, Paid Vacation, Volunteer Time & More
  2. Learning & Development Opportunities

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