Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

• 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
• 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
• 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
• 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

• 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)

Medical device knowledge

• Flexible work arrangements
• Opportunities for career growth
• Supportive and inclusive environment
• Diverse and global client exposure
• Learn from experts