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.
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)