Sobre esta vaga de Regulatory Affair Specialist - Pharma na Brenntag
Brenntag · Presencial · Assago,Italy
Brenntag, the global market leader in the distribution of chemicals and ingredients, supports customers and partners with high-quality technical, commercial, and logistical solutions.
To strengthen our Pharma Business Unit, we are looking for a Regulatory Affairs Specialist with a technical background in pharmaceutical or related industries, particularly with experience in regulatory documentation and compliance.
The successful candidate will join the EMEA team and will be responsible, with a high degree of autonomy, for managing all regulatory aspects of the pharma business across the region.
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.
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 Italian (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.
Our Offer
Salary range: €40,000 – €45,000
The salary range indicated in this job posting represents an average estimate for the position. The final compensation package will be determined based on the selected candidate’s experience, skills, and qualifications, in accordance with applicable EU pay transparency and equal pay requirements.
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.
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