Regulatory Affairs Specialist - Pharma Raw Materials

About the role

Brenntag, a global leader in chemicals and ingredients distribution, is hiring a Regulatory Affairs Specialist for its EMEA Pharma Business Unit in Barcelona or Valencia. You will support the EMEA division on regulatory, quality, compliance, legal and product stewardship topics for a large portfolio of raw materials supplied to the pharmaceutical industry. The role is primarily office-based, with occasional travel for supplier meetings, customer visits, audits or internal workshops.

Key responsibilities

• Prepare, review and issue technical and regulatory documentation for pharmaceutical customers, such as Quality and Technical Agreements, Supply Chain Statements, Regulatory Questionnaires and Compliance Statements (TSE/BSE, GMO, allergens, nitrosamines, residual solvents, elemental impurities)
• Ensure documentation is accurate, consistent and aligned with pharmacopoeias, IPEC Guidelines, EU GDP and GMP guidelines
• Gather regulatory, quality and technical information from internal sources and suppliers, and evaluate supplier documentation for completeness and compliance
• Log and track customer documentation requests using defined KPIs, identify trends and gaps, and lead regulatory deliverables for customer-specific projects and new product introductions
• Support change control evaluations and customer notifications
• Work with QHSE and supply chain teams to ensure compliance with IPEC GMP/GDP, EXCiPACT, GDP and other standards, and implement new regulatory requirements
• Partner with commercial and value-added services teams, contribute to global Pharma Regulatory team projects, and deliver training to commercial, supply chain and internal teams

Required profile

• Degree in a life science discipline (chemistry, biochemistry, pharmaceutical sciences) or equivalent relevant experience
• Strong knowledge of pharmaceutical industry requirements for APIs, excipients, biopharma materials and traditional pharma raw materials
• Understanding of European National Competent Authority requirements for distribution of APIs, excipients and raw materials
• Fluent in English and Spanish, spoken and written
• Willingness to undertake occasional travel

Required skills

• Excellent written communication and ability to produce compliant documentation
• Ability to interpret regulations, resolve compliance issues and answer complex regulatory queries
• High attention to detail and strong organisational skills

What we offer

• The opportunity to join a global industry leader
• An international, collaborative and dynamic work environment
• Continuous learning and career development opportunities