Lead Regulatory Affairs Expert

vor 3 Monaten

Neuss, Nordrhein-Westfalen, Deutschland Kenvue Vollzeit

Position Overview

The role of the Senior Regulatory Affairs Specialist is pivotal in shaping regulatory strategies across the EMEA region, providing essential regulatory insights and technical guidance to product development teams within the Skin / Essential Health sector.

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 areas.
  • Foster effective collaborations with R&D, Franchise (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/or Essential Health Franchise.

Regulatory Strategy

  • Collaborate with local and regional regulatory colleagues to formulate global and regional regulatory strategies.
  • Organize materials from preclinical and clinical studies for review and facilitate the review process.
  • Prepare and submit regulatory submissions in accordance with applicable requirements and guidelines.
  • Coordinate meetings with internal stakeholders and regulators, developing and organizing necessary materials.
  • Monitor the status of applications under regulatory review and provide updates to the regulatory team.
  • Stay informed on 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 and opportunities arising from changes in the regulatory landscape.
  • Participate in the development and implementation of compliance processes, SOPs, and working instructions.
  • Ensure accuracy and maintenance of enterprise regulatory systems.
  • Review and escalate compliance issues, implementing corrective and preventive actions as necessary.
  • Identify and implement regional process improvement opportunities and support global or regional regulatory initiatives.
  • Assist in internal and external audits and inspections in collaboration with the quality function.

Regulatory Advocacy

  • Monitor the regulatory environment, maintaining resources on 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

  • Partner with the business to achieve regulatory outcomes that align with business objectives.
  • Work independently with strategic direction, impacting operational results within the business unit.

Other Responsibilities

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

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