Senior Regulatory Affairs Associate - Portugal Local Regulatory Responsible Person

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We are seeking an experienced 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.

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 INFARMED submission 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)