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.

Job Description

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 regulat

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