Regulatory Manager (Labeling Devices) - Temporary job opportunity at AbbVie.

Home Jobs In Spain Tag: Job Regulatory Manager (Labeling Devices) - Temporary position at AbbVie


Date2026-04-10T13:05:26.822Z bot
AbbVie Regulatory Manager (Labeling Devices) - Temporary
Experience: General
Pattern: Full-time
Country:
apply Apply Now
Salary:
Status:

Job

Copy Link Report
degreeMaster's (M.A.)
loacation Madrid, Community of Madrid, Spain
loacation Madrid, Commun..........Spain
Auto GPT Summarize Enabled
Job DescriptionProvide advice and counsel on EU MDR, device labeling and global translation process, communicating closely with impacted stakeholders.Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labeling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.Ensure consistency of EU device and drug product labeling across assigned product lines and compliance with AbbVie policies and procedures.Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure AbbVie products have most competitive labeling. Maintain awareness of recent competitor approvals in class/region for assigned products.Agree timelines for submission and implementation of drug product or device label changes through interface with RA Area product owners, Brand managers, supply chain, Global Label Management (GLM) and other functions as required.Maintain active awareness of all relevant EU legislation and guidance relevant to EU devices / product information/ labeling and assess impact on AbbVie business and R&D programs, in collaboration with RPI.Provide information for artwork briefs for EU, for device and drug product production artwork describe and communicate content and agreed timelines of changes to affiliates & GLM, provide master mock-ups/word documents to enable redlining in the EU. Present updates/forecasts to affiliates/LCC and other stakeholders at regular (bi-weekly) affiliate meetings for assigned products/devices.Lead or support project work related to device labeling improvements or compliance or systems.Support inspection readiness activities for assigned products.Lead readability testing strategy for assigned products – including drafting bridge tests when needed and vendor management where required.Take responsibility for device website maintenance for assigned products where applicable.Manage the device labeling in the RIM system, including routing and approvals.Support and provide guidance for other team members and products when required.External representation for device labeling topics.

Other Ai Matches

Medical Manager Oncology Applicants are expected to have a solid experience in handling Job related tasks
Principal Research Scientist II, Analytical Development Applicants are expected to have a solid experience in handling Analytical Development related tasks
Associated Director, International Learning Neuroscience Portfolio Applicants are expected to have a solid experience in handling International Learning Neuroscience Portfolio related tasks
Associate Director, Innovation Applicants are expected to have a solid experience in handling Innovation related tasks