Regulatory Affairs Specialist
hace 2 días
Massalfassar
Regulatory Affairs Specialist – Barcelona / Valencia EMEA Pharma Business Unit At Brenntag, the global market leader in chemicals and ingredients distribution, we're looking for a Regulatory Affairs Specialist to join our team in Barcelona or 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. Es esencial asegurarse de que cumple con los requisitos como solicitante para este puesto; por favor, lea atentamente la información a continuación. Role Overview As 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 Responsibilities • Customer Documentation & Regulatory Support: Prepare, review, and issue technical and regulatory documentation required by pharmaceutical customers, including Quality & Technical Agreements, Supply Chain Statements, Regulatory Questionnaires, Compliance 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 Engagement: Source 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 Management: Log, 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 Projects: Lead 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 Implementation: Work 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 Collaboration: Partner 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 Sharing: Deliver 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 Responsibilities: Perform any other tasks within capability to support the commercial, regulatory, and compliance success of the Pharma business unit.Your Profile, • Qualification & Experience: 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)., • 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. 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. About Brenntag Brenntag is the leading global distributor of chemicals and ingredients, committed to connecting customers and suppliers within networks. We add value for our customers and partners every step of the way: through our product knowledge, innovation, and sustainable solutions, combined with our passion for service excellence and commitment to safety. Headquartered in Essen, Germany, and with more than 17,500 experts at about 600 locations in 72 countries, our two global divisions, Brenntag Essentials and Brenntag Specialties, offer a full range of industrial and specialty chemicals and ingredients. Therefore, our clients and partners can count on us for global reach combined with local agility and execution. As an employer, we embrace diversity and foster a sense of community and collaboration in an environment where employees are encouraged to share ideas and work together. We engage our employees in the company’s mission for collective success, by building long‑term stability and safety through trust and clarity across the organization. xcskxlj We believe in empowering our employees to reach their full potential and shape the future. For more information, please visit J-18808-Ljbffr
