At a Glance
- Tasks: Manage regulatory activities for iconic healthcare brands and ensure compliance with regulations.
- Company: Join Kenvue, a leader in consumer healthcare with a culture that values every voice.
- Benefits: Enjoy hybrid work, competitive salary, and opportunities for personal and professional growth.
- Other info: Collaborative environment with diverse teams and excellent career advancement opportunities.
- Why this job: Make a real impact on health products that improve lives globally.
- Qualifications: Bachelor's degree and 4+ years of regulatory experience required.
The predicted salary is between 40000 - 50000 £ per year.
Kenvue is currently recruiting for a 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’re 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: Associate Director, Regulatory Affairs
Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire
Work Location: Hybrid
What you will do
The Regulatory Affairs Specialist is responsible for all regulatory activities associated with assigned medicines within their geographical and/or brand area of responsibility. This role involves the compilation and submission of applications (new submissions and post-approval), resolution of Health Authority questions in cooperation with other functions, and the management of post-approval commitments and variations/renewal applications as needed.
- Assist in the development of regulatory strategies across the EMEA region, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
- Coordinate, compile, and submit new drug applications to regulatory agencies within their geographical and/or brand area of responsibility.
- Manage MRP, DCP, and Workshare submission activities for medicines.
- Develop effective partnerships with R&D, Franchise (Marketing), and local regulatory colleagues.
- Collect and evaluate information on regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
- Prepare and submit regulatory submissions for the registration and maintenance of products throughout their lifecycle, according to applicable regulatory requirements and guidelines.
- Monitor the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals where possible.
- Prioritise, plan, and monitor allocated projects against defined timelines.
- Develop and maintain a thorough understanding of the regulatory environment and supporting data requirements.
Regulatory Compliance
- Ensure that all assigned products comply with local regulatory and quality system requirements.
- Maintain logs of communication and outcomes with regulators and other relevant internal or external stakeholders.
- Stay aware of current regulations and anticipate implications and opportunities arising from changes in the regulatory environment.
- Participate in the development and implementation of applicable processes, SOPs, and working instructions.
- Ensure that enterprise regulatory systems are accurate and fully maintained.
- Review and escalate compliance issues, implementing relevant corrective/preventative actions locally.
- Identify and implement regional process improvement opportunities and ensure the implementation of relevant global or regional regulatory initiatives.
- Assist in the preparation for internal and external audits and inspections in collaboration with others.
Specific Requirements
- Relevant Bachelor's Degree or higher.
- 4+ years of related regulatory experience.
- Represent Regulatory Affairs on cross-functional product/project teams and provide regulatory advice.
- Apply organisational understanding and awareness in decision-making.
- Utilise effective communication and influencing skills to develop key relationships with internal/external contacts.
Essential Knowledge
- Knowledge of the consumer healthcare environment and product development.
- Hands-on experience with regulatory requirements and registration activities for medicines in the EU/EMEA.
- Understanding of regulatory frameworks and external environments, with the ability to apply these to regulatory solutions throughout the product lifecycle.
- Solid understanding of regulatory, medical, safety, and quality requirements in relevant markets.
- Familiarity with processes and departments within a healthcare company.
Core Competencies:
- Excellent communication skills, capable of articulating concepts clearly both verbally and in writing, especially when simplifying complex regulatory or technical issues.
- Strong interpersonal skills; able to build effective personal networks internally and externally.
- Collaborative with a strong sense of ownership, accountability, and recognition for delivering results.
- Strong organisational and time management skills, with the ability to work under pressure.
- Ability to work effectively in a multi-cultural, highly matrixed organisation.
- Proficiency in English.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Regulatory Affairs Specialist in Sonning Common employer: KENVUE
Kenvue is an exceptional employer that prioritises the well-being and growth of its employees, offering a vibrant work culture where every voice is valued. Located in Reading, Berkshire, our hybrid work model fosters flexibility while providing access to a wealth of resources and opportunities for professional development within the consumer healthcare sector. Join us to make a meaningful impact on millions of lives through our iconic brands and innovative products.
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We think this is how you could land Regulatory Affairs Specialist in Sonning Common
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We think you need these skills to ace Regulatory Affairs Specialist in Sonning Common
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at KENVUE!
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How to prepare for a job interview at KENVUE
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at KENVUE that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
