Senior EU Labelling Associate (Regulatory Affairs)

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 [email protected]