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: Hybrid work model with excellent learning and development opportunities.
- 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 are 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 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).
- 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 Mansfield employer: KENVUE
Kenvue is an exceptional employer that prioritises the well-being and growth of its employees, offering a competitive benefits package alongside a vibrant work 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.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Mansfield
✨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 recent news. Show them you’re not just another candidate; you’re genuinely interested in their mission and values.
✨Tip Number 3
Practice makes perfect! Get a friend to do a mock interview with you. Focus on articulating your experience clearly, especially around regulatory affairs, so you can impress them with your expertise.
✨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.
We think you need these skills to ace Senior Regulatory Affairs Specialist in Mansfield
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Regulatory Affairs Specialist role. Highlight your relevant experience, especially in EU regulatory procedures like MRP/DCP, and showcase your attention to detail and communication skills.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for Kenvue. Share your passion for regulatory affairs and how your background aligns with our mission of delivering exceptional care through science.
Showcase Your Achievements:Don’t just list your responsibilities; highlight your achievements in previous roles. Use specific examples that demonstrate your ability to manage projects, communicate effectively, and navigate complex regulatory environments.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity at Kenvue!
How to prepare for a job interview at KENVUE
✨Know Your Regulatory Stuff
Make sure you brush up on EU regulatory requirements, especially around MRP and DCP. Familiarise yourself with the latest guidelines and be ready to discuss how your experience aligns with Kenvue's needs.
✨Showcase Your Communication Skills
Since this role requires excellent communication, practice articulating complex regulatory concepts in simple terms. Prepare examples of how you've successfully communicated with health authorities or internal teams in the past.
✨Demonstrate Your Organisational Skills
Be prepared to discuss how you prioritise and manage multiple projects under tight deadlines. Share specific strategies you've used to keep track of submissions and ensure compliance with regulations.
✨Emphasise Collaboration
Kenvue values teamwork, so think of examples where you've worked effectively with cross-functional teams. Highlight your ability to build relationships and how that has helped you achieve regulatory goals.
