Overview In this role you will lead regulatory strategies and global 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 general 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 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