Regulatory Affair Specialist

12 ago - Roma
Settore aeronautico e aerospaziale

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.

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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

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