Regulatory Affairs Specialist - Brenntag

Brenntag; Lérida; Presencial; EUR 42.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Career development

Meaningful projects

Equal opportunities

Global leader

Descripción de la vacante

Brenntag is seeking a Regulatory Affairs Specialist to support regulatory, quality and product stewardship for a pharma raw materials portfolio in the Barcelona/Valencia area. You will deliver audit-ready documentation and drive regulatory deliverables for bespoke projects, collaborating across functions and occasionally traveling to supplier meetings and audits.

Responsibilities include preparing regulatory documents, ensuring alignment with GMP/GDP and pharmacopoeia, sourcing regulatory

Formación

• Degree in life science or equivalent experience.
• Strong knowledge of APIs, excipients and biopharma materials.
• Understanding of European regulatory requirements for APIs and raw materials.
• Fluent in English and Spanish; strong written communication.

Responsabilidades

• Prepare, review and issue 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.

Conocimientos

Regulatory knowledge

APIs & excipients

Biopharma materials

English fluency

Spanish fluency

Documentation writing

Cross-functional collaboration

Educación

Life science degree

Descripción del empleo

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.

• continuous learning and career development
• meaningful projects with real impact
• equal employment opportunities
• global industry leader
• 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
• 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
• proactive mindset
• pharmaceutical regulatory knowledge (APIs, excipients)
• GMP/GDP, IPEC, EXCiPACT
• documentation and compliance drafting

Regulatory Affairs Specialist - Brenntag • granollers, catalunya, es