At a Glance
- Tasks: Lead regulatory activities for EMEA medicinal products and ensure compliance with EU regulations.
- Company: Join Kenvue, a dynamic company focused on consumer healthcare.
- Benefits: Enjoy a competitive benefits package, paid holidays, and learning opportunities.
- Other info: Hybrid work model with a collaborative and multicultural environment.
- Why this job: Make a real impact in healthcare by navigating complex regulatory landscapes.
- Qualifications: 6+ years of regulatory experience and a relevant degree required.
The predicted salary is between 55000 - 65000 € per year.
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.
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 & 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.
Required 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 be rewarded for delivering results.
- Strong organizational 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.
Benefits
- Competitive Benefit Package.
- Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More.
- Learning & Development Opportunities.
- Employee Resource Groups.
Senior Regulatory Affairs Specialist in Reading employer: Kenvue-1
Kenvue is an exceptional employer that values its employees by offering a competitive benefits package, including paid holidays and opportunities for volunteer time, all within a supportive hybrid work environment in Reading, Berkshire. The company fosters a collaborative culture that encourages professional growth through learning and development initiatives, making it an ideal place for those seeking meaningful and rewarding careers in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist in Reading
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU regulatory requirements and recent changes in the industry. We recommend practising common interview questions with a friend to boost your confidence.
✨Tip Number 3
Showcase your experience! When you get the chance to discuss your past projects, highlight your successes in managing regulatory submissions and working with health authorities. We want to see how you can bring that expertise to our team.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who take the initiative to connect directly with us.
We think you need these skills to ace Senior Regulatory Affairs Specialist in Reading
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 and DCP. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for this role. Share specific examples of your past work that relate to regulatory submissions and compliance. We love a good story!
Show Off Your Communication Skills:Since this role requires excellent communication skills, make sure your application reflects that. Keep your language clear and concise, and don’t shy away from showcasing your ability to simplify complex regulatory issues. We appreciate clarity!
Apply Through Our Website:We encourage you to apply through our website for a smoother process. It helps us keep track of applications better and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Kenvue-1
✨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 specific regulations and how they apply to the role will show that you're not just familiar with the basics but are genuinely invested in the field.
✨Showcase Your Communication Skills
Since this role requires excellent communication skills, prepare to demonstrate how you've effectively articulated complex regulatory issues in the past. Think of examples where your clear communication made a difference, whether in written submissions or verbal discussions with health authorities.
✨Highlight Your Project Management Experience
Be ready to talk about your experience in prioritising and managing multiple regulatory projects. Use specific examples to illustrate how you've met tight deadlines and navigated challenges, showcasing your organisational skills and ability to work under pressure.
✨Demonstrate Collaboration
This position involves working closely with various functions, so be prepared to discuss how you've successfully collaborated in previous roles. Share stories that highlight your interpersonal skills and how you've built effective networks, both internally and externally.
