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 a competitive benefits package, paid holidays, and learning opportunities.
- Other info: Hybrid work environment with a culture that values every voice.
- Why this job: Make a real impact on health products that improve lives every day.
- Qualifications: Bachelor's degree and 6+ years of regulatory experience required.
The predicted salary is between 55000 - 65000 € per year.
Kenvue is currently recruiting for a Senior Regulatory Affairs Specialist.
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.
Our global team is approximately 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
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).
What You Will Do:
- 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 and 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:
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 Sonning Common 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. Located in Reading, Berkshire, our hybrid work model provides flexibility while you contribute to iconic brands that impact millions daily. With competitive benefits, ample learning and development opportunities, and a commitment to employee growth, Kenvue is the perfect place for passionate individuals looking to make a meaningful difference in the world of healthcare.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Sonning Common
✨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 how it relates to regulatory affairs and compliance.
✨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 Sonning Common
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Senior Regulatory Affairs Specialist role. Highlight your relevant experience in regulatory submissions and your understanding of EU regulations. We want to see how your skills align with what we do at Kenvue!
Showcase Your Communication Skills:Since excellent communication is key for this role, don’t shy away from demonstrating your ability to simplify complex regulatory issues in your application. Use clear and concise language to show us you can articulate your thoughts effectively.
Highlight Your Collaborative Spirit:We value teamwork at Kenvue, so make sure to mention any experiences where you've successfully collaborated with others. Whether it’s working with health authorities or cross-functional teams, let us know how you’ve built effective networks.
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 the role. Plus, it gives you a chance to explore more about Kenvue and our amazing culture!
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, prepare examples of how you've simplified complex regulatory issues in the past. Think about times when your clear communication made a difference in project outcomes.
✨Demonstrate Your Organisational Skills
Be ready to talk about how you prioritise and manage multiple projects under tight deadlines. Share specific strategies or tools you use to stay organised and ensure compliance with regulatory timelines.
✨Emphasise Collaboration
Kenvue values teamwork, so think of examples where you've successfully partnered with other functions. Highlight your ability to build effective networks and how that has helped you achieve results in previous roles.
