Regulatory Affairs Expert

Vor 6 Tagen

Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit
About the Role

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
  • Manage and coach a team of regulatory professionals to ensure effective regulatory compliance and strategy implementation.
  • Evaluate and coordinate regulatory deliverables for cosmetic and medical devices within your geographical and/or brand area of responsibility.
  • Develop effective partnerships with R&D, Franchise (Marketing), and local regulatory colleagues to ensure seamless collaboration and regulatory alignment.
  • Assist in the preparation of dossiers and submission packages for the registration and maintenance of products throughout their lifecycle.
  • Represent the Regulatory Affairs function as appropriate within the Skin &/or Essential Health Franchise.
Regulatory Strategy
  • Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinating regulatory actions and results.
  • Develop global/regional dossiers to support local review processes.
  • Organize materials from preclinical and clinical studies for review and assist in the review process.
  • Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
  • Assist in the scheduling of meetings with internal stakeholders and regulators and develop and organize materials for these meetings.
Regulatory Compliance
  • Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
  • 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 the enterprise Regulatory systems are accurate and fully maintained.
  • Ensure any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
Regulatory Advocacy
  • Monitor the regulatory environment (specific regulations, guidance, and other relevant information by product types, geography, etc.) and maintain information resources.
  • Support trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level (if relevant).
Requirements
  • Partners with the business to deliver regulatory outcomes to enable committed business plans within area of responsibility.
  • Works with strategic direction to perform with independent judgment and execution which directly impacts the operational results of the business unit.

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