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 / Ventajas
- 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 teamsResponsabilidades
- 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 occasionallyRequisitos principales
- international, collaborative environment
- continuous learning and career development
- meaningful projects with real impact
- equal employment opportunities
- global industry leader