Sr Reg Affairs Specialist Self Care

TN United Kingdom; High Wycombe; Hybrid; GBP 50,000 - 75,000; Full time

Job summary

An innovative company seeks a Senior Regulatory Affairs Specialist to lead the development of regulatory strategies across the EMEA region. This role involves coordinating regulatory actions, preparing submissions, and ensuring compliance with evolving regulations. You will collaborate with diverse teams, providing technical guidance and support for product development. Join a passionate team dedicated to delivering exceptional care and impactful products that enhance everyday lives. If you thrive in a dynamic environment and are eager to make a difference, this opportunity is perfect for you.

Qualifications

• Experience in developing regulatory strategies across EMEA.
• Strong understanding of regulatory requirements and guidelines.

Responsibilities

• Develop global/regional regulatory strategies and dossiers.
• Prepare and submit regulatory submissions according to guidelines.
• Monitor regulatory developments and maintain communication logs.

Skills

Regulatory Strategy Development

Regulatory Submissions

Compliance Monitoring

Stakeholder Communication

Technical Guidance

Education

Bachelor's Degree in Life Sciences

Master's Degree in Regulatory Affairs

Tools

Regulatory Management Software

Job description

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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