Senior Regulatory Affairs Associate - Portugal Local Regulatory Responsible Person

We are seeking an experiencedSenior Regulatory Affairs Associateto 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 Spanish markets.The role can be home or office based in Spain.

Key Responsibilities

Strategic Execution & Compliance Management

• Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities

• Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations

• Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure

• Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams

Health Authority Engagement & Submissions

• Serve as primary interface with INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), industry groups, and trade associations

• Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations

• Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements

• Monitor status of submitted regulatory activities and ensure timely completion

Lifecycle Management & Compliance

• Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions

• Ensure timely submission of renewals and mandated post-approval applications

• Maintain RIMS database with current local activity and track compliance KPIs

• Oversee compliant labelling (RCM, Folheto Informativo, packaging) including updates, translations, and promotional material review

Cross-Functional Collaboration

• Act as primary RA representative for local Commercial Operations (ComOps)

• Support regional regulatory TA teams within GRA for efficient planning and submission preparation

• Collaborate with Global Labelling for Foundational Labelling Processes

Experience & Expertise

• University degree in a life science discipline

• Minimum 5 years' experience in Portuguese Regulatory Affairs, with strong understanding of Portuguese and EU regulatory requirements

• Proven experience with multiple submission types: CP, MRP, DCP, and National procedures

• Comprehensive lifecycle management expertise for Portuguese submissions

• Experience with INFARMEDsubmission processes and requirements

• Competence in labelling management (updates, mock-up review, and print release processes)

• Medical device knowledge advantageous, but not essential

• Familiarity with systems such as Veeva Vault

• Excellent organizational, time management, and interpersonal skills in a global environment

• Proven ability to work effectively both independently and in teams

• Strong project management and leadership capabilities

• Expertise in influencing stakeholders and driving business-critical decisions

• Fluent in Portuguese and English (oral and written)