Descripción del trabajo
Experteer Overview In this role you will coordinate European regulatory activities to maintain and obtain marketing authorizations across Europe. You will work closely with GRL, country affiliates, and cross-functional teams to drive timely regulatory submissions and lifecycle management. You will develop regulatory strategies and provide expert advice on EU rules, helping to shape the company’s European portfolio. This is a hands-on, collaborative position with exposure to major EU procedures and multi-country projects.
Compensaciones / Ventajas

Maintain and submit post-approval variations and new MAs across Europe in collaboration with regional teams
Coordinate regulatory activities in Europe, EEA, UK, and other relevant regions
Prepare and review regulatory documentation aligned with corporate objectives and interact with EMA and national regulators
Develop and implement regulatory strategies for registered products, development projects, and new applications
Provide regulatory guidance on EU regulations and guidelines to cross-functional teams




Represent European Regulatory Affairs on non-product projects and collaborate with stakeholders
Support regulatory activities in non-European countries as needed
Ensure timely submission of MA documentation via CP/MRP/DCP with cross-functional coordination
Lifecycle management to maintain compliance and high-quality submissions
Manage complex submissions (groupings, super-grouping, work-sharing) and classify variations
Coordinate labeling changes with Labelling Team and prepare product information
Prepare responses to Health Authority queries and monitor regulatory milestones
Offer regulatory input in governance meetings and act as RA representative on cross-functional teams
Improve processes to meet business objectives while ensuring compliance
Understand downstream impact of regulatory changes on local operations
Maintain up-to-date scientific and regulatory knowledge for assigned products
Adhe

📌 Senior Specialist Regulatory Affairs, European Union Countries (Madrid)
🏢 Organon u0026
📍 Madrid