At a Glance
- Tasks: Manage regulatory activities for EMEA medicinal products and ensure compliance with EU regulations.
- Company: Join Kenvue, a leader in consumer healthcare with iconic brands like NEUTROGENA® and TYLENOL®.
- Benefits: Enjoy competitive pay, paid holidays, volunteer time, and summer Fridays!
- Other info: Collaborative culture with opportunities for personal and professional growth.
- Why this job: Make a real impact in healthcare while working in a supportive, innovative environment.
- Qualifications: Bachelor’s degree and 6+ years of regulatory experience required.
The predicted salary is between 60000 - 75000 £ per year.
Kenvue is currently recruiting for a Senior Regulatory Affairs Specialist.
What we do
At Kenvue, we realise 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® that you already know and love. Science is our passion; care is our talent.
Who We Are
Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.
Role reports to: Senior CMC Manager
Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire
Work Location: Hybrid
What you will do
The Senior Regulatory Affairs Specialist is accountable for all regulatory activities associated with EMEA medicinal products. Projects may include compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested. This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).
- Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing marketing authorisations.
- Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
- Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Prioritises, plans and monitors allocated projects against defined timelines.
- Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.
- Ensures that all assigned products comply with local regulatory and quality system requirements.
- Assists in ensuring that the enterprise Regulatory systems are accurate and fully maintained.
- Identifies & initiates local process improvement opportunities and manages changes as required.
- Assists in the preparation for internal and external audits and inspections in collaboration with others.
- Partners with other critical functions to execute plans to address crises and other sensitive issues.
Qualifications
- Relevant Bachelor’s Degree or higher
- 6+ years related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
- Good attention to detail.
- Excellent communication skills, with the ability to articulate and express concepts clearly both verbally and in writing, particularly when simplifying complex regulatory or technical issues.
- Good interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, willing to be held accountable and rewarded for delivering results.
- Strong organisational and time management skills with an ability to work under pressure.
- Able to work effectively in a multi‑cultural, highly matrixed organization.
- Proficiency in English.
Desired Qualifications
- Knowledge of consumer healthcare environment and product development.
- Understanding of processes and departments within a healthcare company.
- Effective time and organisation management.
What’s In It For You
- Competitive Benefit Package
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
- Learning & Development Opportunities
- Employee Resource Groups
For individuals with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Senior Regulatory Affairs Specialist in Reading employer: Dormont Manufacturing Co
Kenvue is an exceptional employer that prioritises the well-being and growth of its employees, offering a competitive benefits package alongside a vibrant workplace culture where every voice is valued. Located in Reading, Berkshire, this hybrid role as a Senior Regulatory Affairs Specialist provides unique opportunities for professional development and collaboration within a diverse team dedicated to making a positive impact on millions of lives through science and care.
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We think you need these skills to ace Senior Regulatory Affairs Specialist in Reading
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