Experteer Overview
Join Brenntag as a Regulatory Affairs Specialist in the Barcelona/Valencia area to support regulatory, quality, and product stewardship for a broad pharma raw materials portfolio. You will deliver accurate, audit-ready documentation to pharmaceutical customers and drive regulatory deliverables for bespoke projects. The role involves cross-functional collaboration, process improvement, and occasional travel to supplier meetings and audits. You’ll help ensure materials meet EU and international pharmaceutical standards and contribute to regulatory excellence across the business.
Compensaciones / Incentivos
• Prepare, review and issue technical and regulatory documentation for pharma customers (Quality u0026 Technical Agreements, Supply Chain Statements, Regulatory Questionnaires, Compliance Statements)
• Ensure documents align with pharmacopoeia, IPEC Guidelines, EU GDP and GMP
• Source and evaluate regulatory, quality and technical information from internal and supplier sources
• Log, track and report customer documentation requests using KPIs and identify process improvements
• Lead regulatory deliverables for customer-specific projects and coordinate data collection for new product introductions
• Support change control evaluations and customer notifications
• Work with QHSE and supply chain to ensure compliance with standards (IPEC GMP/GDP, EXCiPACT, GDP, etc)
• Contribute to global Pharma Regulatory projects and harmonisation efforts
• Deliver training on regulatory topics to commercial, supply chain and internal teams
• Perform other tasks to support regulatory and compliance success
• Cross-functional collaboration with commercial and value-added services teams
Responsabilidades
• Degree in life science or equivalent experience
• Strong knowledge of APIs, excipients, biopharma materials, and traditional pharma materials
• Understanding of European National Competent Authority requirements for distribution of APIs and raw materials
• Fluent in English and Spanish (written and spoken)
• Strong written communication to produce compliant documentation
• Excellent collaboration and proactive cross-functional work
• Ability to interpret regulations and resolve compliance issues
• High attention to detail and organisational skills
• Willingness to travel occasionally
Requisitos principales
• international, collaborative environment
• continuous learning and career development
• meaningful projects with real impact
• equal employment opportunities
• global industry leader