Senior Regulatory Affairs Associate – Local Regulatory Responsible Person

Role Overview

• Provide local input 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 initiatives with industry groups and trade associations
• Act as the Regulatory Affairs representative in audits and inspections, ensuring readiness and timely closure of CAPAs
• Monitor changes in the regulatory landscape and communicate requirements to Global Regulatory Affairs (GRA) and local teams
• Serve as the 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 product licences, partner regulatory licences, and market access collaborations
• Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
• Monitor the status of submitted regulatory activities and ensure timely completion
• Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
• Ensure timely submission of renewals and other mandated post-approval applications
• Maintain the RIMS database with current local activities and track compliance KPIs
• Oversee compliant labelling (RCM, Folheto Informativo, packaging), including updates, translations, and review of promotional materials
• Act as the primary Regulatory Affairs representative for local Commercial Operations (ComOps)
• Support regional regulatory TA teams within GRA for efficient planning and submission preparation
• Collaborate with Global Labelling on foundational labelling processes

Requirements

• Minimum of 5 years' experience in Portuguese Regulatory Affairs
• Strong understanding of Portuguese and EU regulatory requirements
• Proven experience with multiple submission types: Centralised Procedure (CP), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP), and National procedures
• Comprehensive lifecycle management expertise for Portuguese submissions
• Experience with INFARMED submission processes and requirements
• Competence in labelling management (updates, mock-up review, and print release processes)
• Medical device knowledge is 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 as part of a team
• Strong project management and leadership capabilities
• Demonstrated ability to influence stakeholders and drive business-critical decisions
• Fluency in Portuguese and English (spoken and written)

Tech Stack

• Vault

Benefits

• Flexible work arrangements
• Professional development