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- Tasks: Lead labelling strategy and develop key documents for product life cycles.
- Company: Join a dynamic team in a leading regulatory affairs company, focused on innovation.
- Benefits: Enjoy flexible remote work options and a supportive work environment.
- Why this job: Make an impact in regulatory affairs while collaborating with experienced professionals.
- Qualifications: Must have experience with CCDS, EU, and USPI labelling.
- Other info: This is a 12-month remote contract role outside IR35.
The predicted salary is between 48000 - 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.
Senior Manager, Global Labelling, Regulatory employer: Hays
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 in labelling. Engaging in discussions or attending relevant webinars can provide insights and potentially lead to referrals.
✨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.
✨Tip Number 4
Research StudySmarter's values and mission to align your responses during interviews. Showing that you resonate with our culture can set you apart from other candidates and demonstrate your enthusiasm for joining our team.
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 to 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 how you've done this in the past.
Follow Application Instructions: Ensure you follow the application instructions carefully. Submit your CV and cover letter as specified, and double-check for any additional documents that may be required.
How to prepare for a job interview at Hays
✨Know Your Labelling Regulations
Make sure you have a solid understanding of the regulations surrounding CCDS, EU and USPI. Be prepared to discuss how your experience aligns with these requirements and how you've successfully navigated similar challenges in the past.
✨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, especially when dealing with executive committees.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past experiences where you had to make critical decisions regarding labelling documents and be ready to explain your thought process.
✨Demonstrate Team Collaboration
Highlight your ability to work with cross-functional teams. Discuss how you've collaborated with product teams and senior management to align on labelling strategies, showcasing your leadership and teamwork skills.
