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POSITION SUMMARY / MISSION
The Associate Director, Regulatory Affairs is responsible for leading regulatory strategies and operations to support the development, registration, and lifecycle management of Assigned Almirall’s pharmaceutical products across integral markets. This role ensures regulatory compliance, drives submission excellence, and provides strategic input into cross-functional development plans.



The position collaborates closely with internal stakeholders and health authorities to enable timely approvals and maintain regulatory integrity throughout the product lifecycle.

CORE RESPONSIBILITIES

Define and implement global regulatory strategies for development and marketed products

Lead the preparation and submission of regulatory dossiers (e.g., CTA, MAA, variations, renewals) in alignment with regional requirements

Provide regulatory guidance to cross-functional teams including Clinical, CMC, Safety, and Market Access

Manage interactions with health authorities and respond to regulatory queries

Ensure compliance with applicable regulations, guidelines, and internal procedures

Monitor regulatory changes and assess impact on Almirall’s portfolio and operations

Support due diligence and licensing activities from a regulatory perspective

Contribute to the development and maintenance of regulatory systems, tools, and SOPs

Represent Regulatory Affairs in internal governance and decision-maki

📌 ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (Madrid)
🏢 Almirall
📍 Madrid