At a Glance
- Tasks: Manage regulatory activities for iconic brands and ensure compliance with EU regulations.
- Company: Join Kenvue, a leader in everyday care with a culture that values every voice.
- Benefits: Enjoy competitive pay, paid holidays, volunteer time, and summer Fridays!
- Other info: Hybrid work model with opportunities for learning and development.
- Why this job: Make a real impact on health products that people love and trust.
- Qualifications: Bachelor's degree and 6+ years of regulatory experience required.
The predicted salary is between 60000 - 75000 £ per year.
At Kenvue, we realise the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we are the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love. 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.
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).
Key Responsibilities:
- 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.
Qualifications:
- Relevant Bachelor's Degree or higher.
- 6+ years related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
- 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.
- Able to build effective personal networks internally and externally.
- Proficiency in English.
Competitive Benefit Package: Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More! Learning & Development Opportunities.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Regulatory Specialist and Senior Specialist in Wokingham employer: KENVUE
At Kenvue, we pride ourselves on being an exceptional employer, offering a vibrant workplace culture where every voice is valued and innovation thrives. Our commitment to employee growth is evident through our extensive learning and development opportunities, alongside a competitive benefits package that includes paid holidays, vacation, and unique perks like Summer Fridays. Located in Reading, our hybrid work model allows for flexibility while contributing to the success of iconic brands that make a difference in everyday care.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Specialist and Senior Specialist in Wokingham
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Kenvue on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by knowing your stuff! Research Kenvue’s products and their regulatory processes. Show them you’re not just another candidate; you’re genuinely interested in their mission and how you can contribute.
✨Tip Number 3
Practice makes perfect! Get a friend to do mock interviews with you. Focus on articulating your experience clearly, especially around regulatory affairs. The more comfortable you are, the better you'll perform!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the Kenvue team. Let’s get you that job!
We think you need these skills to ace Regulatory Specialist and Senior Specialist in Wokingham
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Senior Regulatory Affairs Specialist. Highlight your relevant experience in regulatory submissions and compliance, and don’t forget to mention any specific projects that align with the job description.
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your skills can contribute to Kenvue’s mission. Keep it concise but impactful!
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your application reflects your ability to articulate complex ideas clearly. Use straightforward language and avoid jargon where possible.
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It’s the best way to ensure your application gets the attention it deserves, and you’ll find all the details you need there!
How to prepare for a job interview at KENVUE
✨Know Your Regulations
Make sure you brush up on the latest EU regulatory requirements and guidelines, especially those related to MRP and DCP. Being able to discuss these in detail will show that you're not just familiar with the basics but are genuinely invested in the role.
✨Showcase Your Communication Skills
Since excellent communication is key for this position, prepare examples of how you've simplified complex regulatory issues in the past. Think about times when your clear communication helped resolve a problem or facilitated a project.
✨Demonstrate Project Management Prowess
Be ready to talk about how you've prioritised and monitored projects against timelines in previous roles. Use specific examples to illustrate your ability to manage multiple regulatory submissions and ensure compliance.
✨Engage with the Company Culture
Kenvue values a workplace where every voice matters. Research their culture and think about how your personal values align with theirs. Be prepared to discuss how you can contribute to their commitment to care and innovation.
