Job Description

The Position

Coordinating and supporting all regulatory activities to maintain registrations and to obtain new marketing authorizations for the company portfolio/pipeline subject to EU procedures (Centralized, Mutual Recognition, Decentralized, National authorized Procedures) across therapeutic areas. The position also requires strong project management skills to oversee regulatory initiatives, manage timelines effectively, and facilitate collaboration within cross-functional teams.

Responsibilities

Ensure the maintenance of marketing authorizations across Europe for assigned products by preparing and submitting post-approval applications in a timely manner, in collaboration with the GRL and European country affiliates.
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.
Develop and implement regulatory strategies for registered products, development projects, and new marketing authorization applications.
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 general levels, and country affiliates as needed.
Maintain compliance of marketing authorizations with regulatory requirements by performing lifecycle management activities, incl

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