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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.
- Benefits: Enjoy flexible working options and a supportive team environment.
- Why this job: Make an impact in regulatory affairs while working on exciting projects remotely.
- Qualifications: Experience with CCDS, EU and USPI labelling is essential.
- Other info: This is a 12-month contract role 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.
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 during 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 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 labelling negotiations. This will showcase your expertise and problem-solving skills.
✨Tip Number 4
Research the company’s products and their current labelling strategies. Being able to speak knowledgeably about their portfolio during your conversation will set you apart and show your genuine interest in the role.
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. Mention your ability to influence decisions and provide labelling guidance, as well as your familiarity with scientific data.
Showcase Your Achievements: In both your CV and cover letter, include quantifiable achievements related to labelling projects. This could be successful negotiations, improvements in labelling processes, or contributions to high-quality documentation.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
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 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 involves working closely with product teams and senior management. Be ready to discuss how you've successfully collaborated with cross-functional teams in the past, and how you can bring that experience to the new role.
