We are seeking an experienced Senior Regulatory Affairs Associate to serve as the Spain 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.
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 AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), 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 (Ficha Técnica, Prospecto, 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 Spanish Regulatory Affairs, with strong understanding of Spanish and EU regulatory requirements
* Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
* Comprehensive lifecycle management expertise for Spanish submissions
* Experience with AEMPS 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 Spanish and English (oral and written)
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