At a Glance
- Tasks: Manage regulatory activities for EMEA medicinal products and ensure compliance with EU regulations.
- Company: Join Kenvue, a leader in everyday care 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 in EU procedures required.
The predicted salary is between 51750 - 63250 £ 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.
- Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates.
- 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 manage 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:
- Required Qualifications:
- Relevant Bachelor's Degree or higher.
- 6+ years related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
- Proven track record in EU regulatory procedures (MRP/DCP), with solid experience in non-CMC lifecycle management and safety updates.
- Good attention to details.
- 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 be 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 organisation.
- 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.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Senior Regulatory Affairs Specialist in Wargrave employer: KENVUE
Kenvue is an exceptional employer that champions a culture of inclusivity and innovation, making it a fantastic place for a Customer Development Executive to thrive. With a commitment to employee growth and a hybrid work model based in Reading, Berkshire, Kenvue offers unique opportunities to impact everyday care while being part of a global team that values every voice. Join us to not only advance your career but also contribute to the well-being of millions through our iconic brands.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Wargrave
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We think you need these skills to ace Senior Regulatory Affairs Specialist in Wargrave
Some tips for your application 🫡
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How to prepare for a job interview at KENVUE
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at KENVUE that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
