Regulatory Affairs Specialist
1 month ago
Kenvue is a leading house of iconic brands, built on over a century of heritage and rooted in science. We're passionate about insights, innovation, and committed to delivering the best products to our customers.
As a Senior Regulatory Affairs Specialist, you will play a critical role in developing regulatory strategies across the EMEA region and globally. You will provide regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
Key Responsibilities:
- Develop global and/or regional regulatory strategies, coordinating regulatory actions and results.
- Organize materials from preclinical and clinical studies for review and assist in the review process.
- Prepare and submit regulatory submissions according to applicable regulatory requirements and guidelines.
- Assist in scheduling meetings with internal stakeholders and regulators and develop and organize materials for these meetings.
- Track the status of applications under regulatory review and provide updates to the regulatory team.
- Familiarize and understand current regulatory legislation to keep legislative knowledge up to date at regional level.
- Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
- Participate in the development and implementation of, and maintain compliance with, all applicable Processes, SOPs and working instructions.
- Ensure that the enterprise Regulatory systems are accurate and fully maintained.
- Identify and/or implement regional process improvement opportunities and ensure implementation of relevant global or regional regulatory initiatives.
- Support internal and external audits and inspections in collaboration with quality function.
- Monitor the regulatory environment and maintain information resources.
- Support trade association, working groups, developing impact assessments, influencing strategies, and leading solutions at EU and local level.
Requirements:
- Primary Location: Europe/Middle East/Africa-United Kingdom-England-High Wycombe
- Job Function: Regulatory Affairs
Kenvue is a global team of 22,000 diverse and brilliant people, passionate about insights, innovation, and committed to delivering the best products to our customers. We put people first, care fiercely, earn trust with science, and solve with courage. If you're passionate about regulatory affairs and want to be part of a dynamic team, apply now
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