We are seeking an experienced
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Obtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas.
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Senior Regulatory Affairs Associate to serve as the Portugal Local Regulatory Responsible (LRR), focusing on local regulatory requirements and Health Authority national engagements. In this client-facing role, you will have an opportunity to work in a complex global matrix organization, serving as a subject matter expert and making meaningful contributions to regulatory strategy and compliance. You will collaborate with diverse teams across regions and play a crucial role in ensuring regulatory excellence for Portuguese markets. The role can be home or office based in Spain.
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Key Responsibilities
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Health Authority Engagement & Submissions
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Serve as primary interface with INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), industry groups, and trade associations
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Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
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Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
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Monitor status of submitted regulatory activities and ensure timely completion
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Lifecycle Management & Compliance
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Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
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Ensure timely submission of renewals and mandated post-approval applications
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Maintain RIMS database with current local activity and track compliance KPIs
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Oversee compliant labelling (RCM, Folheto Informativo, packaging) including updates, translations, and promotional material review
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Cross-Functional Collaboration
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Act as primary RA representative for local Commercial Operations (ComOps)
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Support regional regulatory TA teams within GRA for efficient planning and submission preparation
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Collaborate with General Labelling for Foundational Labelling Processes
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Experience & Expertise
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University degree in a life science discipline
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Minimum 5 years' experience in Portuguese Regulatory Affairs, with strong understanding of Portuguese and EU regulatory requirements
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Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
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Comprehensive xugodme lifecycle management expertise for Portuguese submissions
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Experience with INFARMED submission processes and requirements
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Competence in labelling management (updates, mock-up review, and print release processes)
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Medical device knowledge advantageous, but not essential
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Familiarity with systems such as Veeva Vault
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Excellent organizational, time management, and interpersonal skills in a global environment
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Proven ability to work effectively both independently and in teams
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Strong project management and leadership capabilities
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Expertise in influencing stakeholders and driving business-critical decisions
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Fluent in Portuguese and English (oral and written)