Regulatory Affairs Specialist (Granollers)

Regulatory Affairs Specialist (Granollers)

16 sep
|
Brenntag
|
Granollers

16 sep

Brenntag

Granollers

Overview
La experiencia que se espera de los solicitantes, así como las habilidades y cualificaciones adicionales necesarias para este trabajo, se enumeran a continuación.
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
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 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
Requisitos principales
Degree in life science or equivalent experience
Strong knowledge of APIs, excipients, biopharma xqbhyrx 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

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