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- Tasks: Lead labelling strategy and develop key documents for product life cycles.
- Company: Join a leading client in the Regulatory Affairs sector, offering remote work opportunities.
- Benefits: Enjoy flexible working options and a supportive team environment.
- Why this job: Make an impact in regulatory affairs while working on exciting projects with a dynamic team.
- Qualifications: Experience in developing CCDS, EU, and USPI is essential for this role.
- Other info: This is a 12-month remote contract position outside IR35.
The predicted salary is between 43200 - 72000 £ per year.
One of my clients is looking for an experienced Regulatory Affairs Labelling Professional to join the team on a 12-month contracting basis. This is a remote contract job outside IR35.
The key role as Senior Labelling Manager is to develop and maintain core labelling documents and create EU and USPI, or provide support for any other local product information throughout the product life cycle in accordance with processes, and to provide labelling guidance to support product teams and senior management in defining labelling strategy.
As Senior Labelling professional, you will influence labelling team decisions based on precedent labelling negotiations experience and get alignment on proposed CCDS wording. Present proposed CCDS and key differences with EU-USPI to the Executive Labelling Committee (ELC) with the support of the product team to obtain internal approval before submission of major labels.
Review scientific data, write effectively and summarise in the appropriate detail for labelling content. Provide input for the production of high-quality documents supporting changes to labelling content.
It is essential that those Labelling professionals applying for this contract job have experience of developing the CCDS, EU and USPI.
Flexible working options available.
If you’re interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn’t quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.
Contact Detail:
Hays Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Global Labelling, Regulatory
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to labelling in both the EU and US. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs community, especially those who have experience with CCDS and labelling strategies. Engaging in discussions can provide insights and potentially lead to referrals for the position.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully influenced labelling decisions or navigated complex regulatory challenges. This will showcase your expertise and problem-solving skills during the interview.
✨Tip Number 4
Research the company’s products and their current labelling strategies. Being knowledgeable about their portfolio will allow you to tailor your discussions and show how you can contribute to their goals.
We think you need these skills to ace Senior Manager, Global Labelling, Regulatory
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in developing CCDS, EU and USPI. Use specific examples from your previous roles that demonstrate your expertise in regulatory affairs and labelling.
Craft a Compelling Cover Letter: Write a cover letter that outlines your relevant experience and how it aligns with the responsibilities of the Senior Manager role. Emphasise your ability to influence decisions and provide labelling guidance.
Showcase Your Communication Skills: In your application, highlight your ability to review scientific data and summarise it effectively for labelling content. This is crucial for the role, so provide examples of documents you've produced in the past.
Follow Application Instructions: Ensure you follow the application instructions carefully. Submit your CV and cover letter through our website, and double-check for any specific requirements mentioned in the job description.
How to prepare for a job interview at Hays
✨Know Your Labelling Regulations
Familiarise yourself with the latest EU and US labelling regulations. Be prepared to discuss how your experience aligns with these requirements, as this will demonstrate your expertise in developing CCDS and USPI.
✨Showcase Your Communication Skills
As a Senior Manager, you'll need to present complex information clearly. Prepare examples of how you've effectively communicated labelling strategies or influenced decisions in previous roles to highlight your ability to convey important information.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of specific instances where you had to navigate labelling negotiations or resolve conflicts within a team, and be ready to share these experiences.
✨Demonstrate Your Team Collaboration
This role requires collaboration with various teams. Be ready to discuss how you've worked with product teams and senior management in the past, particularly in aligning labelling strategies and obtaining approvals for major labels.
