Regulatory Affairs Specialist for Skin and Essential Health
vor 17 Stunden
Regulatory Affairs Specialist Job Description
Kenvue is a global leader in the development and manufacture of everyday care products. We are currently seeking a highly skilled Regulatory Affairs Specialist to join our team in Neuss, Germany.
Key Responsibilities:
- Manage and coach a team of regulatory professionals to ensure compliance with regulatory requirements.
- Evaluate and coordinate regulatory deliverables for cosmetic and medical devices.
- Develop effective partnerships with R&D, Franchise, and local regulatory colleagues.
- Assist in the preparation of dossiers and submission packages for registration and maintenance of products.
Regulatory Strategy:
- Work with local and regional regulatory colleagues to develop global and regional regulatory strategies.
- Coordinate regulatory actions and results, and develop global/regional dossiers to support local review processes.
- Organize materials from preclinical and clinical studies for review and assist in the review process.
Regulatory Compliance:
- Maintain logs of communication and outcomes with regulators and other stakeholders.
- Ensure compliance with applicable processes, SOPs, and working instructions.
- Identify and implement regional process improvement opportunities.
Regulatory Advocacy:
- Monitor the regulatory environment and maintain information resources.
- Support trade association, working groups, impact assessments, and influencing strategies at EU and local level.
Requirements:
- Partners with the business to deliver regulatory outcomes.
- Works with strategic direction to perform with independent judgment and execution.
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