Senior Regulatory Affairs Associate Spain Local Regulatory Responsible Person
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Job Location:
Monthly Salary:
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds 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 were committed to making a difference.
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 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)
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
