Overview

Aumente sus posibilidades de conseguir una entrevista leyendo la siguiente descripción general de este puesto antes de presentar su candidatura.

In this role you will lead regulatory strategies and general 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 xqziphu 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)
🏢 Jobrapido
📍 Barcelona