At a Glance
- Tasks: Lead regulatory CMC strategy for new product development and lifecycle management.
- Company: Join Kenvue, a leader in everyday care with iconic brands.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative culture where every voice matters and career growth is encouraged.
- Why this job: Make a real impact on global health with your expertise in regulatory affairs.
- Qualifications: 10+ years in regulatory affairs and strong project management skills required.
The predicted salary is between 63000 - 77000 £ per year.
Kenvue is currently recruiting for a Regulatory Affairs CMC Manager.
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: DIRECTOR Global & EMEA Regulatory Affairs OTC
Location: Europe/Middle East/Africa, Sweden, Skane, Helsingborg
Work Location: Hybrid
What you will do
- End-to-end responsibility for Module 3/CMC new product development and life cycle management.
- Acts as regulatory CMC lead in new product development projects with responsibility for regulatory CMC strategy development and deployment.
- Leads a team of regulatory affairs CMC product owners with responsibility for Module 3/CMC maintenance ensuring the success of life cycle management activities and roll-out of existing products.
- Provides technical leadership and expertise to cross-functional R&D partners and life cycle management teams to support development of fit for purpose CTD Module 3/CMC documentation for marketing authorization applications and variations globally.
- Develop strong partnerships with Regulatory Affairs partners, R&D, Marketing and Supply Chain.
- Represents the Regulatory Affairs CMC function as appropriate in various regulatory and cross-functional teams and technical fora.
- Creates an environment of operational excellence through regulatory expertise, management of CMC product owners and collaboration with cross-functional teams.
Knowledge and skills
- Relevant Bachelor's Degree or higher.
- 10+ years experience from regulatory affairs and/or pharmaceutical product development.
- Expertise across regulatory classifications including medicinal products and medical devices as it relates to pharmaceutical CMC regulatory affairs.
- Knowledge of regulatory frameworks globally as it concerns pharmaceutical product development and CMC requirements.
- Experienced in developing and maintaining Module 2.3 and 3 and providing guidance to cross-functional partners in authoring CTD documents.
- Strong project and people management skills.
- Highly collaborative and strong sense of ownership.
- Proficiency in English.
Background checks in the recruitment process
As a final candidate in our recruitment process, you may be subject to a background check. This process is important for us to ensure the quality of our recruitment process. As part of this, it is important that we encourage you to make sure that the information in your CV is correct before submitting your application to us. To carry out these background checks, we use a background check company. Different checks may be carried depending on the position that you are applying for. This could be, for example: Reference checks, CV-validation, Financial checks, Litigation checks, including criminal cases. The background check company is an independent data controller for any personal data that they will process during the check, and if you have any questions about the processing, you may turn to the background check company. Due to our business activities and daily operations, we may also carry out drug tests as part of our recruitment process. If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Regulatory Affairs CMC Manager in Henley on Thames employer: Kenvue
At Kenvue, we foster a vibrant work culture where every voice is valued and innovation thrives. As a Product Lifecycle Manager in Reading, you'll enjoy a hybrid work environment, competitive benefits, and ample opportunities for professional growth while contributing to the success of iconic brands that impact millions. Join us to be part of a team that prioritises care, collaboration, and continuous improvement in the supply chain landscape.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs CMC Manager in Henley on Thames
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Kenvue. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Kenvue.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Kenvue. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Kenvue is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs CMC Manager in Henley on Thames
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!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Kenvue that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Kenvue!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Kenvue, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
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.
✨Showcase Relevant Experience
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
Take some time to familiarise yourself with Kenvue’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
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.
