At a Glance
- Tasks: Manage regulatory submissions and ensure compliance for EMEA medicinal products.
- Company: Join Kenvue, a leader in consumer healthcare with a collaborative culture.
- Benefits: Enjoy a competitive benefits package, paid holidays, and summer Fridays.
- Other info: Work in a dynamic, multicultural environment with great career growth.
- Why this job: Make a real impact in healthcare by navigating regulatory challenges.
- Qualifications: Experience in regulatory affairs and strong organisational skills required.
The predicted salary is between 50000 - 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 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.
Senior Regulatory Affairs Specialist employer: Kenvue-1
Kenvue is an exceptional employer that fosters a collaborative and inclusive work culture, offering a hybrid working model in the vibrant location of Reading, Berkshire. Employees benefit from a competitive package that includes generous paid holidays, volunteer time, and unique perks like Summer Fridays, all while having ample opportunities for professional growth within the dynamic field of regulatory affairs in the healthcare sector.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Regulatory Affairs Specialist
✨Tip Number 1
Network like a pro! Reach out to people in the regulatory affairs field, especially those at Kenvue. A friendly chat can open doors and give you insights that might just help you stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU regulatory requirements. We want to see that you’re not just familiar with the basics but also ready to tackle specific challenges in the role.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you've managed multiple projects under pressure. We love candidates who can juggle tasks while keeping everything on track.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in joining our team at Kenvue.
We think you need these skills to ace Senior Regulatory Affairs Specialist
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 in regulatory submissions and compliance, and don’t forget to showcase your organisational skills!
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 at Kenvue. Mention specific projects or experiences that align with the job description and show us your passion for regulatory affairs.
Showcase Your Communication Skills:Since the role involves liaising with Health Authorities, make sure to demonstrate your strong communication skills in your application. Use clear and concise language, and don’t hesitate to share examples of how you've effectively communicated in past roles.
Apply Through Our Website:We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us!
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 relevant to medicinal products. 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 that you’re genuinely invested in the field.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully prioritised and managed projects in the past. Highlight your ability to meet deadlines and handle multiple tasks simultaneously, as this is crucial for the Senior Regulatory Affairs Specialist role.
✨Communicate Effectively
Practice articulating your thoughts clearly and concisely. Since the role involves liaising with Health Authorities, being able to communicate complex information in an understandable way is key. Consider doing mock interviews to refine your communication skills.
✨Demonstrate Collaboration
Be ready to discuss how you've built effective networks both internally and externally. Share specific instances where collaboration led to successful outcomes, as this will highlight your ability to work in a multi-cultural, matrixed environment.
