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- Tasks: Coordinate EU labeling reviews and ensure quality translations for product information.
- Company: Join a dynamic team in regulatory affairs, making an impact in the healthcare industry.
- Benefits: Earn £19.00 per hour with flexible work arrangements, including 3x a week on-site.
- Why this job: Be part of a crucial process that ensures compliance and quality in product labeling.
- Qualifications: Bachelor’s degree in a scientific field; strong communication and multitasking skills required.
- Other info: Must be able to travel to site 3x a week and have the right to work in the UK.
Job role: Senior EU Labelling Associate (Regulatory Affairs)
Job Type: 12-Month Contract PAYE
Location: Bracknell, Berkshire, UK – 3x a week on-site
Rate: £19.00 per hour
Role responsibilities:
- Coordinate EU competent authority linguistic review of centralized translations by working with affiliates to arrange the preparation and revision of EU product information (PI) translations.
- Check the consistent implementation of changes in English PI, perform a high-level quality check of final translated PI and mock-ups before submission to EMA or competent authorities.
- Development of submission mock-ups, based on label text received from Regional Regulatory scientists, branding information provided by Marketing and considering layouts defined by the applicable manufacturing site.
- Support the Regional Regulatory scientists on the timely submission of specimens.
- Launch material review to ensure alignment with approved mock-ups.
- Under supervision of Regional Regulatory scientists, lead submission and implementation of administrative label changes including simple notifications or variations.
- Act as a delegate for some Affiliate labeling implementation responsibilities outlined in the Labeling Development and Maintenance standard.
- Support Affiliate Labeling Responsible Person (ALRP) in submission activities related to the Artwork Request Form (ARF) Process and printed sample requests.
- Maintain understanding and expertise of local and regional regulations related to labeling implementation.
- Communicate approval of new and revised EU PI to internal functions.
- Support the ARF process associated with label changes and help resolve any local ARFs questions or issues.
- Work with Regional Regulatory scientists, ALRPs, PPMD and Supply Chain to agree the best timing for the implementation of new or revised labeling and bundling changes when appropriate.
- Support and act as back-up for other Regional Labeling Coordinators as capacity allows.
- Provide ALRP training and train and assist affiliates on the use of systems/tools.
- Assist with deviations and escalations related to labeling implementation.
- Advise Regulatory Scientists on Readability User Test (RUT) requirements and timing; provide justification of bridging or other strategic features; contact the vendor to conduct RUTs according to standards.
- Develop, improve, and maintain tools to retain labeling information.
- Lead, partner and influence labeling-related activities throughout the product lifecycle, including communication with affiliates for submission activities related to the ARF process and samples and implementation of local labeling. Understand and communicate manufacturing impact (cost and resources) associated with labeling changes.
- Share timely information with other Regional Labeling Coordinators to capitalize on best practices.
- Educate affiliates, when necessary, on regulatory requirements, roles, and responsibilities, labeling best practices (QRD template, truth copy preparation, ARF) and the process to ensure high quality translations and timely implementation of new or revised labeling.
- Drive timely implementation of labeling changes ensuring regulator and internal timelines are met.
- Demonstrate understanding of labeling implementation process and determine impact. Communicate impact of labeling changes to cross-functional partners.
- Develop submission and implementation plans to capitalize upon opportunities for bundling changes for more efficient implementation, when applicable.
Requirements/qualifications:
- Education Requirements: Bachelor’s degree in a scientific or health sciences discipline (or equivalent experience).
- Demonstrated ability to coordinate and manage multiple tasks simultaneously.
- Good communication skills.
- Demonstrated attention to detail.
- Demonstrated competence of computer skills (e.g., Word, Excel, PowerPoint).
- Demonstrated agility to learn new IT systems/tools.
- Demonstrated effective teamwork skills; able to adapt to diverse interpersonal styles.
- Demonstrated ability to work independently.
- Demonstrated problem solving skills.
Please note you must be able to travel to site 3x a week and hold the full right to work in the UK.
For more information please contact lucy.kirkaldy@cpl.com
Senior EU Labelling Associate employer: Cpl Life Sciences
Contact Detail:
Cpl Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior EU Labelling Associate
✨Tip Number 1
Familiarize yourself with the EU labeling regulations and guidelines. Understanding the specific requirements for product information translations will give you an edge in discussions during the interview.
✨Tip Number 2
Highlight your experience with cross-functional collaboration. Since this role involves working closely with Regional Regulatory scientists and affiliates, showcasing your teamwork skills can set you apart.
✨Tip Number 3
Prepare to discuss your problem-solving abilities. Be ready to provide examples of how you've successfully navigated challenges in previous roles, especially related to regulatory affairs or labeling.
✨Tip Number 4
Demonstrate your attention to detail by discussing specific instances where your meticulousness led to successful outcomes. This is crucial in ensuring high-quality translations and compliance with regulations.
We think you need these skills to ace Senior EU Labelling Associate
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior EU Labelling Associate position. Highlight key responsibilities and qualifications that match your experience.
Tailor Your CV: Customize your CV to emphasize relevant experience in regulatory affairs, labeling, and project management. Use specific examples that demonstrate your attention to detail and ability to manage multiple tasks.
Craft a Strong Cover Letter: Write a cover letter that connects your background to the role. Mention your understanding of EU regulations and your experience with labeling processes. Show enthusiasm for the opportunity to work with the team.
Highlight Communication Skills: Since good communication skills are essential for this role, provide examples in your application that showcase your ability to collaborate with cross-functional teams and educate others on regulatory requirements.
How to prepare for a job interview at Cpl Life Sciences
✨Understand the Role Responsibilities
Make sure you thoroughly understand the key responsibilities of a Senior EU Labelling Associate. Be prepared to discuss how your previous experiences align with tasks like coordinating linguistic reviews and managing submission mock-ups.
✨Showcase Your Attention to Detail
Since this role requires a high level of quality checks and attention to detail, be ready to provide examples from your past work where your meticulousness made a difference in the outcome of a project.
✨Demonstrate Communication Skills
Effective communication is crucial in this position. Prepare to discuss how you've successfully communicated with cross-functional teams or affiliates in the past, especially regarding regulatory requirements and labeling best practices.
✨Highlight Your Problem-Solving Abilities
Be ready to share specific instances where you faced challenges related to labeling implementation or regulatory compliance and how you approached solving those issues. This will demonstrate your capability to handle the complexities of the role.
