Senior Regulatory Affairs Associate - Portugal Local Regulatory Responsible Pers

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 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 Portuguese markets.The role can be home or office based.Key ResponsibilitiesStrategic Execution & Compliance ManagementProvide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activitiesEnsure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associationsAct as RA representative in audits/inspections, ensuring readiness and timely CAPA closureMonitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teamsHealth Authority Engagement & SubmissionsServe as primary interface with INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.), industry groups, and trade associationsLead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborationsPrepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirementsMonitor status of submitted regulatory activities and ensure timely completionLifecycle Management & ComplianceManage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissionsEnsure timely submission of renewals and mandated post-approval applicationsMaintain RIMS database with current local activity and track compliance KPIsOversee compliant labelling (RCM, Folheto Informativo, packaging) including updates, translations, and promotional material reviewCross-Functional CollaborationAct as primary RA representative for local Commercial Operations (ComOps)Support regional regulatory TA teams within GRA for efficient planning and submission preparationCollaborate with Global Labelling for Foundational Labelling ProcessesExperience & ExpertiseUniversity degree in a life science disciplineMinimum 5 years' experience in Portuguese Regulatory Affairs, with strong understanding of Portuguese and EU regulatory requirementsProven experience with multiple submission types: CP, MRP, DCP, and National proceduresComprehensive lifecycle management expertise for Portuguese submissionsExperience with INFARMEDsubmission processes and requirementsCompetence in labelling management (updates, mock-up review, and print release processes)Medical device knowledge advantageous, but not essentialFamiliarity with systems such as Veeva VaultExcellent organizational, time management, and interpersonal skills in a global environmentProven ability to work effectively both independently and in teamsStrong project management and leadership capabilitiesExpertise in influencing stakeholders and driving business-critical decisionsFluent in Portuguese and English (oral and written)Originally posted on Himalayas