Lead Regulatory Affairs Expert

vor 2 Monaten

Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit

Position Overview

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

Key Responsibilities

  • Oversee and mentor a team of regulatory professionals.
  • Assess and coordinate regulatory deliverables for cosmetic and medical devices within designated geographical and brand responsibilities.
  • Foster effective collaborations with R&D, Franchise (Marketing), and local regulatory teams.
  • Assist in preparing documentation and submission packages for product registration and lifecycle management.
  • Act as a representative for the Regulatory Affairs function within the Skin and/or Essential Health Franchise.

Regulatory Strategy

  • Collaborate with local and regional regulatory colleagues to formulate global and/or regional regulatory strategies.
  • Organize materials from preclinical and clinical studies for review and facilitate the review process.
  • Prepare and submit regulatory applications in accordance with applicable requirements and guidelines.
  • Coordinate meetings with internal stakeholders and regulators, developing necessary materials for these discussions.
  • Monitor the status of applications under regulatory review and provide updates to the regulatory team.
  • Stay informed about current regulatory legislation to maintain up-to-date knowledge at the regional level.

Regulatory Compliance

  • Maintain records of communications and outcomes with regulators and relevant stakeholders.
  • Stay aware of current regulations and anticipate implications of changes in the regulatory landscape.
  • Participate in the development and implementation of compliance processes, SOPs, and working instructions.
  • Ensure the accuracy and maintenance of enterprise regulatory systems.
  • Review and escalate compliance issues, implementing corrective and preventive actions as necessary.
  • Identify and implement opportunities for regional process improvements and ensure adherence to global or regional regulatory initiatives.
  • Support internal and external audits and inspections in collaboration with the quality function.

Regulatory Advocacy

  • Monitor the regulatory environment, including specific regulations and guidance relevant to product types and geography.
  • Engage in trade associations and working groups, developing impact assessments and influencing strategies at both EU and local levels.

Qualifications

  • Collaborate with the business to achieve regulatory outcomes that align with committed business plans.
  • Operate with strategic direction, exercising independent judgment that directly influences operational results.

Other Responsibilities

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

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