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Sr Reg Affairs Specialist Self Care, High Wycombe
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Client:
Kenvue
Location:
High Wycombe, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
032db4010ec9
Job Views:
8
Posted:
24.04.2025
Expiry Date:
08.06.2025
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Job Description:
Senior Regulatory Affairs Specialist – Self Care
The Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies across the EMEA region and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise. This position reports to the Associate Director of Regulatory Affairs and is based at High Wycombe (hybrid).
Who We Are
At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON’S, and BAND-AID. Science is our passion; care is our talent. Our global team of 22,000 diverse and brilliant people is passionate about insights, innovation, and committed to delivering the best products to our customers. Being a Kenvuer means having the power to impact the lives of millions of people every day. We put people first, care fiercely, earn trust with science, and solve with courage. Join us in shaping our future—and yours. For more information, visit our website.
What You Will Do
* Work with local and regional regulatory colleagues to develop global and/or regional regulatory strategies, coordinate regulatory actions, 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.
* 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 stay updated with current regulatory legislation at the regional level.
* Maintain logs of communication and outcomes with regulators and other relevant stakeholders.
* Monitor the regulatory environment for changes and implications, and anticipate opportunities.
* Participate in the development and maintenance of compliance with all applicable processes, SOPs, and working instructions.
* Ensure accuracy and maintenance of enterprise regulatory systems.
* Review and escalate compliance issues and implement corrective actions.
* Identify and implement regional process improvement opportunities and support global/regional initiatives.
* Support internal and external audits and inspections in collaboration with quality functions.
* Monitor regulatory developments and maintain information resources.
* Support trade associations, working groups, impact assessments, and influence strategies at EU and local levels.
* Provide technical and leadership development as appropriate.
* Monitor progress of applications for self/direct reports, minimizing delays and anticipating difficulties.
* Partner with the business to deliver regulatory outcomes supporting business plans.
* Work with strategic direction and independent judgment to impact operational results.
Qualifications
Primary Location: Europe/Middle East/Africa - United Kingdom - England - High Wycombe
Job Function: Regulatory Affairs
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