Lead Regulatory Affairs Consultant

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, offering essential regulatory insights and technical guidance 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 areas.
  • Foster effective collaborations with R&D, Marketing, and local regulatory teams.
  • Assist in the preparation of 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 division.

Regulatory Strategy

  • Collaborate with local and regional regulatory colleagues to formulate global and regional regulatory strategies.
  • Organize materials from preclinical and clinical studies for evaluation and assist in the review process.
  • Prepare and submit regulatory filings in accordance with applicable guidelines.
  • Coordinate meetings with internal stakeholders and regulators, developing 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 logs of communications and outcomes with regulators and relevant stakeholders.
  • Keep abreast of current regulations and anticipate implications from changes in the regulatory landscape.
  • Participate in the development and adherence to applicable processes, SOPs, and working instructions.
  • Ensure accuracy and maintenance of enterprise regulatory systems.
  • Review and escalate compliance issues, implementing corrective actions as necessary.
  • Identify opportunities for regional process improvements and support the implementation of 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, including specific regulations and guidance by product type 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.
  • Exercise independent judgment and execution that directly influences operational results.

Additional 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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