15 sep
|
Brenntag
|
Granollers
15 sep
Brenntag
Granollers
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 / Beneficios international, collaborative environment continuous learning and career development meaningful projects with real impact equal employment opportunities global industry leader
Responsabilidades
Prepare, review and issue technical and regulatory documentation for pharma customers (Quality & 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 integral 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
Requisitos principales 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 collaboration proactive mindset attention to detail pharmaceutical regulatory knowledge (APIs, excipients)
GMP/GDP, IPEC, EXCiPACT documentation and compliance drafting
📌 Regulatory Affairs Specialist (Granollers)
🏢 Brenntag
📍 Granollers