Job Purpose

The Regulatory Affairs Officer will support the execution and coordination of local regulatory activities across Iberia, ensuring compliance with applicable local and European regulatory requirements, internal procedures and integral regulatory direction.

The role will contribute to the maintenance of the marketed portfolio, product information accuracy, regulatory submissions, launch readiness, early access activities and regulatory intelligence. It requires strong attention to detail, sound regulatory judgement and effective collaboration with local and global stakeholders.

Key Responsibilities

• Prepare, adapt and manage local regulatory submissions to Health Authorities, including variations, renewals, national phase documentation and lifecycle maintenance activities, assessing the local impact of regulatory changes and ensuring timely follow-up until completion.

• Manage product information activities, including review, update, distribution and implementation of SmPCs, package leaflets, abbreviated SmPCs,



local product information documents and other regulatory texts. Ensure alignment with approved information, local requirements, official repositories and, where relevant, Therapeutic Positioning Reports (IPTs).

• Review and approve packaging materials, artworks, mock-ups, demo packs and related local labelling documentation, ensuring consistency with approved product information and compliance with local requirements, including specific local elements such as blue box, Braille and national coding requirements.

• Support early access and compassionate use activities by contributing to local strategy discussions, preparing and adapting required documentation, supporting submissions and interactions with Health Authorities, coordinating with global and local functions, and maintaining adequate follow-up, trackers and records.

• Contribute to product launch and pre-launch activities by preparing local regulatory documentation, supporting national

📌 Regulatory Affairs Officer (España)
🏢 Aegisana
📍 España