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.

ResponsabilidadesDefine and implement integral regulatory strategies for development and marketed productsLead preparation and submission of regulatory dossiers (CTA, MAA, variations, renewals) aligned with regional requirementsProvide regulatory guidance to cross-functional teams (Clinical, CMC, Safety, Market Access)Manage interactions with health authorities and respond to regulatory queriesEnsure compliance with regulations, guidelines,



and internal proceduresMonitor regulatory changes and assess impact on portfolio and operationsSupport due diligence and licensing activities from a regulatory perspectiveContribute to development and maintenance of regulatory systems, tools, and SOPsRepresent Regulatory Affairs in internal governance forums Requisitos principalesBachelor’s degree in Life Sciences or Pharmacy; advanced degree preferredMinimum 8 years of experience in Regulatory Affairs in the pharmaceutical industryProven track record in global regulatory submissions and interactions with health authoritiesFluent in EnglishStrong communication and stakeholder managementStrategic thinking and problem-solvingExcellent project management and organizational skillsKnowledge of EU, US and international regulatory frameworksRegulatory submissions and dossier managementRegulatory systems, tools, and SOPs

📌 ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (San Feliú de Llobregat)
🏢 Jobrapido
📍 San Feliú de Llobregat