Lead Regulatory Affairs Consultant

Vor 6 Tagen

Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit

Position Overview

The Senior Regulatory Affairs Specialist plays a pivotal role in shaping regulatory strategies across the EMEA region, providing essential regulatory insights and technical support to product development teams within the Skin / Essential Health division.

Key Responsibilities

  • Lead and mentor a team of regulatory professionals.
  • Assess and coordinate regulatory deliverables for cosmetic and medical devices within designated geographical and brand responsibilities.
  • Establish effective collaborations with R&D, Marketing, and local regulatory teams.
  • Assist in the preparation of regulatory dossiers and submission packages for product registration and lifecycle management.
  • Act as a representative for the Regulatory Affairs function within the Skin and Essential Health divisions.

Regulatory Strategy Development

  • Collaborate with local and regional regulatory colleagues to formulate global and regional regulatory strategies.
  • Organize and review materials from preclinical and clinical studies.
  • Prepare and submit regulatory documents in compliance with applicable regulations.
  • Coordinate meetings with internal stakeholders and regulatory authorities, preparing necessary materials.
  • Monitor the status of regulatory applications and provide updates to the team.
  • Stay informed on current regulatory legislation to ensure compliance at the regional level.

Regulatory Compliance Management

  • Maintain comprehensive logs of communications and outcomes with regulatory bodies and stakeholders.
  • Anticipate implications of regulatory changes and identify opportunities for improvement.
  • Contribute to the development and adherence to relevant processes, SOPs, and working instructions.
  • Ensure accuracy and maintenance of enterprise regulatory systems.
  • Address compliance issues promptly and implement corrective actions as necessary.
  • Identify and implement regional process enhancements aligned with global regulatory initiatives.
  • Support internal and external audits in collaboration with quality assurance teams.

Regulatory Advocacy

  • Monitor the regulatory landscape, including specific regulations and guidance by product type and geography.
  • Engage in trade associations and working groups to influence regulatory strategies at both EU and local levels.

Qualifications

The ideal candidate will partner with the business to achieve regulatory outcomes that align with strategic business objectives, exercising independent judgment that directly influences operational results.

Other Responsibilities

  • Represent Regulatory Affairs on cross-functional teams, providing expert regulatory advice.
  • Utilize effective communication and influencing skills to strengthen relationships with internal and external contacts.

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