Regulatory Affairs Specialist (Masalfasar)

Regulatory Affairs Specialist (Masalfasar)

05 ago
|
Brenntag
|
Masalfasar

05 ago

Brenntag

Masalfasar

ph3We're Hiring | Regulatory Affairs Specialist – Barcelona / Valencia /h3 pEMEA Pharma Business Unit /p pAt bBrenntag /b, the integral market leader in chemicals and ingredients distribution, we're looking for a bRegulatory Affairs Specialist /b to join our team in bBarcelona o Valencia /b. /p pIf you're passionate about regulatory compliance, enjoy working in an international environment, and want to make an impact by supporting regulatory excellence across the business, we'd love to hear from you. /p h3Role Overview /h3 pAs a key member of the Pharma team, you will support the EMEA division on all regulatory, quality, compliance, legal, and product stewardship topics related to the supply of a large portfolio of raw materials into the pharmaceutical industry. Your primary responsibility is to provide accurate, timely, and audit‑ready documentation to pharmaceutical customers and to support regulatory deliverables for bespoke product projects. /p pThe role is primarily office‑based, with occasional travel required for supplier meetings, customer visits, audits, or internal workshops. /p pYou will collaborate closely with commercial, supply chain, QHSE, and supplier partners to ensure that all materials supplied meet applicable pharmaceutical regulations and industry standards. /p h3Key Responsibilities /h3 h3Customer Documentation Regulatory Support /h3 ul liPrepare, review, and issue technical and regulatory documentation required by pharmaceutical customers, including: /li liQuality Technical Agreements /li liSupply Chain Statements /li liRegulatory Questionnaires /li liCompliance Statements (e.g., TSE/BSE, GMO, allergens, nitrosamines, residual solvents, elemental impurities) /li liEnsure all documentation is accurate, consistent and aligned with applicable frameworks (i.e. relevant pharmacopoeia, IPEC Guidelines, EU GDP and GMP guidelines. /li /ul h3Information Gathering Supplier Engagement /h3 ul liSource regulatory, quality, and technical information internally and from suppliers to fulfil customer requests. /li liEvaluate supplier documentation for completeness, compliance,



and suitability for pharmaceutical use. /li /ul h3Customer Request Management /h3 ul liLog, track, and report customer documentation requests using defined KPIs. /li liSupport continuous improvement by identifying trends, gaps, and opportunities to streamline documentation processes. /li /ul h3Support for Customer Value Added Service Projects /h3 ul liLead and manage regulatory deliverables for customer-specific projects. /li liCoordinate regulatory assessments, supplier data collection, and compliance documentation for new product introductions or customised specifications. /li liSupport change control evaluations and customer notifications. /li /ul h3Regulatory Compliance Standards Implementation /h3 ul liWork with QHSE and supply chain teams to ensure compliance with applicable standards (IPEC GMP/GDP, EXCiPACT, GDP, and other regulatory frameworks). /li liSupport implementation of new regulatory requirements and internal standards across the business unit. /li /ul h3Cross‑Functional Collaboration /h3 ul liPartner with commercial and value‑added services teams to provide regulatory expertise for customer projects and commercial initiatives. /li liContribute to global Pharma Regulatory team projects, harmonisation efforts, and continuous improvement activities. /li /ul h3Training Knowledge Sharing /h3 ul liDeliver training to commercial, supply chain, and internal teams on regulatory topics relevant to supply of materials into the pharmaceutical industry. /li liAct as a subject matter expert for documentation, compliance, and regulatory expectations. /li /ul h3Additional Responsibilities /h3 ul liPerform any other tasks within capability to support the commercial, regulatory,



and compliance success of the Pharma business unit. /li /ul h3Your Profile /h3 h3Qualifications Experience /h3 ul liDegree in a life science discipline (chemistry, biochemistry, pharmaceutical sciences) or equivalent relevant experience. /li liStrong knowledge of pharmaceutical industry requirements for APIs, excipients, biopharma materials, and traditional pharma raw materials. /li liUnderstanding of European National Competent Authority requirements for distribution of APIs, excipients, and raw materials. /li /ul h3Skills Competencies /h3 ul liFluent in English and Spanish (spoken and written). /li liStrong written communication skills with the ability to produce clear, accurate, and compliant documentation. /li liExcellent collaboration skills with the ability to work proactively across all levels and functions. /li liAbility to interpret regulations, resolve compliance issues, and respond to complex regulatory queries. /li liHigh attention to detail and strong organisational skills. /li liWillingness to undertake occasional travel for customer meetings, supplier visits, audits, or internal workshops. /li /ul h3What we offer /h3 ul liThe opportunity to join a global industry leader. /li liAn international, collaborative, and dynamic work environment. /li liContinuous learning and career development opportunities. /li liThe chance to contribute to meaningful projects that make a real impact. /li /ul pBrenntag provides equal employment opportunities to qualified applicants and employees of all backgrounds and identities to create a workplace where difference is valued because it forms a resilient and more innovative organization. We do not discriminate on the basis of age, disability, gender identity, sexual orientation, ethnicity, race, religion or belief, parental and family status, or any other protected characteristic. We welcome applications from women, men and non‑binary candidates of all ethnicities and socio‑economic backgrounds. /p pBrenntag TA Team /p /p #J-18808-Ljbffr

📌 Regulatory Affairs Specialist (Masalfasar)
🏢 Brenntag
📍 Masalfasar

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