Regulatory Affairs Specialist

Airbus; Granollers; Presencial; EUR 42.000 - 56.000; Jornada completa

Descripción de la vacante

Brenntag is seeking a Regulatory Affairs Specialist to join our Pharma team in Barcelona or Valencia. You will support regulatory deliverables across the EU, prepare audit-ready documentation for pharma customers, and coordinate with suppliers to ensure compliant materials.

You will collaborate with commercial, supply chain and QA teams, ensuring documentation accuracy and alignment with EU pharmacopoeia and GDP/GMP standards. Travel for supplier meetings and audits may be required.

Formación

• Degree in life science or equivalent with knowledge of pharmaceutical regulations.
• Experience documenting regulatory and quality information for APIs and excipients.
• Familiarity with EU GDP/GMP, IPEC guidelines and compliance standards.

Responsabilidades

• Prepare, review, and issue regulatory documentation required by pharmaceutical customers.
• Source regulatory information from internal and supplier sources and assess suitability for pharma use.
• Log, track, and report customer documentation requests using defined KPIs.
• Lead regulatory deliverables for customer projects and coordinate data collection for new products.
• Support compliance with IPEC GMP/GDP, EXCiPACT, GDP and other regulatory frameworks.
• Collaborate with commercial, supply chain and QA teams, deliver regulatory training.

Conocimientos

Fluent English

Fluent Spanish

Regulatory expertise

Documentation skills

Cross-functional collaboration

Travel willingness

Educación

Life science degree

Descripción del empleo

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 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 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 Qualifications & 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.

Skills & Competencies

• 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.

Brenntag TA Team

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. We believe in empowering our employees to reach their full potential and shape the future.

For more information, please visit www.brenntag.com