About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Senior Manager, Regulatory Affairs Strategic Global Labeling (Europe) Home or Office Based in Europe Reporting to Associate Director, Strategic Global Labeling, Europe Role Objective: As the Senior Manager in Global Labelling, you will lead development for end-to-end product labeling, implement regulatory labeling strategy for marketed products and products in development. The Senior Manager will be responsible for line managing and training, in a matrix environment. You will represent the SGL EU team for content at Labeling Sub Teams, as well as with Operations colleagues for packaging artwork and implementation throughout the EU. Key Responsibilities: Advise EU labeling impact/requirements during early stage product development including draft labelling text, content and layout Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labelling (PI Annex I-III) for pharmaceutical products in Europe for assigned products Complete competitor analysis and maintain awareness of relevant EU legislation relevant to EU product information Provide information for artwork briefs for EU, for production artwork describe and communicate content and agreed agency timelines of changes Collaborate with product WE team, Brand Manager, GLM and others to build launch plans/schedule for artwork and labels for assigned products. Support inspection readiness activities & Label reviews for assigned products Line management of more junior team members and supervision of their products, act as back-up for those products and help with workload and training. Qualifications Competent knowledge of and demonstrated ability to apply EU regulatory guidelines pertaining to product labeling. Must be able to work independently and be flexible with meetings on different time zones at both ends of the working day. Travel Yes, 10 % of the Time Job Type Experienced Schedule Full-time Job Level Code M Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.