Overview
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In this role you will lead regulatory strategies and integral submissions to support Almirall’s dermatology medicines across markets. You’ll ensure compliance and submission excellence while guiding cross-functional teams through development plans and lifecycle management. You will interact with health authorities to enable timely approvals and uphold regulatory integrity. This is a high-impact role in a global, patient-focused organization, offering opportunities to shape regulatory strategy and drive meaningful outcomes.
Responsabilidades
Define and implement global regulatory strategies for development and marketed products
Lead preparation and submission of regulatory dossiers (CTA, MAA, variations, renewals) aligned with regional requirements
Provide regulatory guidance to cross-functional teams (Clinical, CMC, Safety, Market Access)
Manage interactions with health authorities and respond to regulatory queries




Ensure compliance with regulations, guidelines, and internal procedures
Monitor regulatory changes and assess impact on portfolio and operations
Support due diligence and licensing activities from a regulatory perspective
Contribute to development and maintenance of regulatory systems, tools, and SOPs
Represent Regulatory Affairs in internal governance forums
Requisitos principales
Bachelor’s degree in Life Sciences or Pharmacy; advanced degree preferred
Minimum 8 years of xqbhyrx experience in Regulatory Affairs in the pharmaceutical industry
Proven track record in global regulatory submissions and interactions with health authorities
Fluent in English
Strong communication and stakeholder management
Strategic thinking and problem-solving
Excellent project management and organizational skills
Knowledge of EU, US and international regulatory frameworks
Regulatory submissions and dossier management
Regulatory systems, tools, and SOPs

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