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 integral regulatory submissions and interactions with health authorities
• Fluent in English
Requisitos principales
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📌 ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (San Feliú de Llobregat)
🏢 Almirall
📍 San Feliú de Llobregat
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