Associate / Sr Associate / Manager - Regulatory Labeling

About the role

Eli Lilly Cork's Global Labeling Department is looking for an Associate, Senior Associate or Manager to lead the development and maintenance of core labeling documents and oversee their global implementation for drug and combination device products. The role covers United States and Canada packaging and patient labeling, acting as the main interface with the Printing Packaging Development (PPD) organization and driving consistency in labeling processes.

Key responsibilities

• Develop and maintain core labeling (Core Data Sheet, Core Device Labeling and CMC core content), prepare it for approval by the Global Product Labeling Committee and Global Labeling Council, and communicate it to global affiliates.
• Lead US and Canada packaging and patient labeling (Instructions for Use and Quick Reference Guides), liaising with Device Delivery & Connected Solutions and PPD, and coordinate labeling artwork and vendor translations.
• Lead labeling contributions to periodic reports such as the FDA Annual Report and Periodic Safety Update Report, and conduct data integrity reviews of healthcare provider labeling.
• Provide regulatory input on labeling, manage exception requests from affiliates, run periodic compliance assessments and close gaps to improve labeling processes.
• Maintain the end-to-end labeling system, develop and archive documents with version control, and track submissions and approvals.
• Collaborate with business partners, take part in regulatory forums and model the Team Lilly behaviors of Include, Innovate, Accelerate and Deliver.

Required profile

• Bachelor's degree in a scientific or health sciences discipline (or equivalent experience).
• Knowledge of the drug development process.
• Preferred: regulatory experience, knowledge of FDA and Health Canada procedures, project management experience, and proven ability to lead, influence and partner.

Required skills

• Writing, presentation and listening skills, with effective teamwork across geographies.
• Attention to detail and organizational skills.
• Ability to learn new software and technology and to manage strategic and operational tasks.

What we offer

• Anticipated wage of EUR 39,750 to 87,560, depending on education, experience, skills and location.
• Possible company bonus for full-time equivalent employees.
• Healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking.
• Flexible hybrid working, in-house people development, educational assistance and wellbeing initiatives.