Regulatory Affairs Specialist
hace 5 días
Granollers
🚀 We're Hiring | Regulatory Affairs Specialist – Barcelona / ValenciaEMEA Pharma Business UnitAt Brenntag, the global market leader in chemicals and ingredients distribution, we're looking for a Regulatory Affairs Specialist to join our team in Barcelona o Valencia.If 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.Role OverviewAs 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.The role is primarily office‑based, with occasional travel required for supplier meetings, customer visits, audits, or internal workshops.You will collaborate closely with commercial, supply chain, QHSE, and supplier partners to ensure that all materials supplied meet applicable pharmaceutical regulations and industry standards.Key ResponsibilitiesCustomer Documentation & Regulatory SupportPrepare, review, and issue technical and regulatory documentation required by pharmaceutical customers, including:Quality & Technical AgreementsSupply Chain StatementsRegulatory QuestionnairesCompliance Statements (e.g., TSE/BSE, GMO, allergens, nitrosamines, residual solvents, elemental impurities)Ensure all documentation is accurate, consistent and aligned with applicable frameworks (i.e. relevant pharmacopoeia, IPEC Guidelines, EU GDP and GMP guidelines.Information Gathering & Supplier EngagementSource regulatory, quality, and technical information internally and from suppliers to fulfil customer requests.Evaluate supplier documentation for completeness, compliance, and suitability for pharmaceutical use.Customer Request ManagementLog, track, and report customer documentation requests using defined KPIs.Support continuous improvement by identifying trends, gaps, and opportunities to streamline documentation processes.Support for Customer Value Added Service ProjectsLead and manage regulatory deliverables for customer-specific projects.Coordinate regulatory assessments, supplier data collection, and compliance documentation for new product introductions or customised specifications.Support change control evaluations and customer notifications.Regulatory Compliance & Standards ImplementationWork with QHSE and supply chain teams to ensure compliance with applicable standards (IPEC GMP/GDP, EXCiPACT, GDP, and other regulatory frameworks).Support implementation of new regulatory requirements and internal standards across the business unit.Cross-Functional CollaborationPartner with commercial and value-added services teams to provide regulatory expertise for customer projects and commercial initiatives.Contribute to global Pharma Regulatory team projects, harmonisation efforts, and continuous improvement activities.Training & Knowledge SharingDeliver training to commercial, supply chain, and internal teams on regulatory topics relevant to supply of materials into the pharmaceutical industry.Act as a subject matter expert for documentation, compliance, and regulatory expectations.Additional ResponsibilitiesPerform any other tasks within capability to support the commercial, regulatory, and compliance success of the Pharma business unit.Your ProfileQualifications & ExperienceDegree 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.Skills & CompetenciesFluent in English and Spanish (spoken and written).Strong written communication skills with the ability to produce clear, accurate, and compliant documentation.Excellent collaboration skills with the ability to work proactively across all levels and functions.Ability to interpret regulations, resolve compliance issues, and respond to complex regulatory queries.High attention to detail and strong organisational skills.Willingness to undertake occasional travel for customer meetings, supplier visits, audits, or internal workshops.💼 What we offer: The opportunity to join a global industry leader. An international, collaborative, and dynamic work environment. Continuous learning and career development opportunities. The chance to contribute to meaningful projects that make a real impact.Interested in joining us, or know someone who might be a great fit? We'd love to hear from you! Feel free to apply or share this opportunity with your network.Brenntag 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.Brenntag TA TeamSummaryLocation: Massalfassar,Spain; Granollers,SpainType: Full time
