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
- Adhere to leadership and compliance standards and build relationships with authorities
- Collaborate with the European Regulatory Affairs team on functional and cross-functional projectsResponsabilidades
- University graduate in life sciences, preferably pharmacy/pharmacology
- Fluency in English; additional European language highly desirable
- Proficient in regulatory information management systems (Veeva, Ennov) and Power BI; proficient in standard office tools
- Minimum 5 years in pharmaceutical industry with extensive EU regulatory experience
- Experience managing European regulatory procedures and submissions across multiple marketsRequisitos principales
- Equity Plan
- Hybrid work
- Remote work

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