Descripción de la oferta
Experteer 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.
Compensaciones / Beneficios
• 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
Responsabilidades
• 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
Requisitos principales
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