At a Glance
- Tasks: Manage product life cycles and provide regulatory guidance for innovative self-care products.
- Company: Join Kenvue, a leader in everyday care with iconic brands like NEUTROGENA® and TYLENOL®.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Be part of a diverse team that values every voice and fosters innovation.
- Why this job: Make a real impact on health and wellness while working with a passionate team.
- Qualifications: Experience in regulatory affairs and strong communication skills are essential.
The predicted salary is between 45000 - 55000 £ per year.
Kenvue is currently recruiting for a CMC 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: Senior CMC Manager
Location: Europe/Middle East/Africa, United Kingdom, Reading, Berkshire
Work Location: Hybrid
What you will do
- The CMC Specialist is responsible for the Life Cycle Management (LCM) activities of assigned products and/or projects providing regulatory assessments and deploying regulatory technical content across the EMEA region, and globally as relevant, providing regulatory input and technical guidance on regulatory requirements to product development teams within the Self Care franchise.
- Acts as the CMC representative within cross-functional project teams. Accountable for assigned projects and activities, completing work within assigned product portfolio.
- Develops resolution proposals for regulatory CMC issues with the stakeholders.
- Reviews proposed CMC changes for completeness and accuracy, interprets CMC regulatory requirements, deploys technical content, assesses risks and develops contingency proposals.
- Uses technical and scientific knowledge to conduct the analysis of CMC submission documentation.
- Oversees the authoring and review of CMC documentation, coordination and management of regional submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
- Represents the Regulatory Affairs function as appropriate within the Self Care Franchise.
- Provides regulatory support to policy, external engagement, and issue management within the Need State of responsibility and participates in process, simplification & culture-building activities within own team and across enterprise as required.
- Co-responsible for supporting alignment of key processes, ways of working and simplifications across the Regional Regulatory Self Care team.
- Responsible for meeting compliance requirements within team such as SOP trainings, audits etc.
- Partners with other critical functions to execute plans to address crises and other sensitive issues.
Essential duties and responsibilities
- Serves as a CMC lead for the deployment of CMC regulatory technical content, submissions and compliance activities for Self Care medicinal products supporting.
- Provides and supports technical and operational CMC regulatory direction and documentation for assigned projects/products covering post approval activities.
- Leads the preparation of CMC information for submission to regional regulatory agencies, generates and deploys CMC technical content, assesses risks and develops contingency/mitigation plans.
- Acts as the regional CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of implications for technical CMC decisions.
- Primary accountable for assigned CMC programs, managing daily delivery of regulatory and technical activities, including post-approval changes, and ongoing compliance of commercial products in the portfolio.
- May represent CMC during interactions with internal and external partners either directly or in conjunction with Global/EMEA Regulatory Affairs Teams.
- Resolves issues and manages regulatory risks within project teams. Investigates opportunities for regulatory improvement / promotes the use of novel approaches within project team to resolve issues and problems.
Other features of the job
- Represents Regulatory Affairs on cross-functional product/project teams and provides CMC advice.
- Uses effective communication and employs influencing skills to continue to grow key relationships with internal/external contacts.
If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.
Planning Specialist 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 Planning Specialist in Henley on Thames
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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.
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We think you need these skills to ace Planning Specialist 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.
