Overview

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 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