The Position

Responsibilities
- Coordinate, manage, and support regulatory activities across Europe, including EEA, Switzerland, the United Kingdom, and non-EU EEI countries, as needed.
- Oversee the preparation and review of regulatory documentation to align with corporate objectives, maintaining interactions with relevant EU regulatory Agencies, EMA and Country Regulatory Affairs teams.
- Stay updated on relevant EU regulations and guidelines to provide expert regulatory advice.
- Represent European Regulatory Affairs on assigned non-product related projects.
- Build and maintain strong relationships with internal and external stakeholders across regulatory and cross-functional teams.
- Provide support for regulatory activities in non-European countries as needed.
- Ensure the timely preparation and submission of appropriate documentation for new Marketing Authorization Applications through CP, MRP, DCP, working closely with cross-functional teams at regional and integral levels, and country affiliates as needed.




- Maintain compliance of marketing authorizations with regulatory requirements by performing lifecycle management activities, including but not limited to preparation and submission, with a high standard of quality and within agreed timelines, supporting country affiliates where necessary. Supports complex submissions like groupings, super-grouping and work-sharing for CP/MRP/DCP/ NAPs and mixed procedures
- Review and confirm variation classifications while supporting complex regulatory submissions.
- Prepare supportive administrative documents and review submissions where required
- For labelling variations, coordinate labelling requests with the Labelling Team and prepare the necessary product information.
- Oversee the authoring and timely submission of response documents to Health Authority queries.
- Ensure regulatory milestones for assigned projects are achieved and effectively communicated to stakeholders.
- Provide regulatory input and expertise d

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