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Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person
Primary Location: Spain, Madrid Additional Locations: Spain, Remote Job ID R0000038898 Category Regulatory Affairs Date Posted 02/18/2026Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
We are seeking an experiencedSenior Regulatory Affairs Associateto 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)
Employee Insights
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