Regulatory Affair Specialist - Pharma

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ppBrenntag, the global market leader in the distribution of chemicals and ingredients, supports customers and partners with high-quality technical, commercial, and logistical solutions.
/p pTo 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.
/p pThe 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.
/p pAs 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.
/p pThe role is primarily office?based, with occasional travel required for supplier meetings, customer visits, audits, or internal workshops.
/p pYou will collaborate closely with commercial, supply chain, QHSE, and supplier partners to ensure that all materials supplied meet applicable pharmaceutical regulations and industry standards.
/p h3Key Responsibilities /h3 h3Customer Documentation Regulatory Support /h3 ul liPrepare, review, and issue technical and regulatory documentation required by pharmaceutical customers, including: ul liQuality Technical Agreements /li liSupply Chain Statements /li liRegulatory Questionnaires /li liCompliance Statements (e.g., TSE/BSE, GMO, allergens, nitrosamines, residual solvents, elemental impurities) /li /ul /li liEnsure all documentation is accurate, consistent and aligned with applicable frameworks (i.e. relevant pharmacopoeia, IPEC Guidelines, EU GDP and GMP guidelines.) /li /ul h3Information Gathering Supplier Engagement /h3 ul liSource regulatory, quality, and technical information internally and from suppliers to fulfil customer requests.




/li liEvaluate supplier documentation for completeness, compliance, and suitability for pharmaceutical use.
/li /ul h3Customer Request Management /h3 ul liLog, track, and report customer documentation requests using defined KPIs.
/li liSupport continuous improvement by identifying trends, gaps, and opportunities to streamline documentation processes.
/li /ul h3Support for Customer Value Added Service Projects /h3 ul liLead and manage regulatory deliverables for customer?specific projects.
/li liCoordinate regulatory assessments, supplier data collection, and compliance documentation for new product introductions or customised specifications.
/li liSupport change control evaluations and customer notifications.
/li /ul h3Regulatory Compliance Standards Implementation /h3 ul liWork with QHSE and supply chain teams to ensure compliance with applicable standards (IPEC GMP/GDP, EXCiPACT, GDP, and other regulatory frameworks).
/li liSupport implementation of new regulatory requirements and internal standards across the business unit.
/li /ul h3Cross?Functional Collaboration /h3 ul liPartner with commercial and value?added services teams to provide regulatory expertise for customer projects and commercial initiatives.
/li liContribute to global Pharma Regulatory team projects, harmonisation efforts, and continuous improvement activities.
/li /ul h3Training Knowledge Sharing /h3 ul liDeliver training to commercial, supply chain, and internal teams on regulatory topics relevant to supply of materials into the pharmaceutical industry.
/li liAct as a subject matter expert for documentation, compliance, and regulatory expectations.




/li /ul h3Additional Responsibilities /h3 ul liPerform any other tasks within capability to support the commercial, regulatory, and compliance success of the Pharma business unit.
/li /ul h3Qualifications Experience /h3 ul liDegree in a life science discipline (chemistry, biochemistry, pharmaceutical sciences) or equivalent relevant experience.
/li liStrong knowledge of pharmaceutical industry requirements for APIs, excipients, biopharma materials, and traditional pharma raw materials.
/li liUnderstanding of European National Competent Authority requirements for distribution of APIs, excipients, and raw materials.
/li /ul h3Skills Competencies /h3 ul liFluent in English and Italian (spoken and written).
/li liStrong written communication skills with the ability to produce clear, accurate, and compliant documentation.
/li liExcellent collaboration skills with the ability to work proactively across all levels and functions.
/li liAbility to interpret regulations, resolve compliance issues, and respond to complex regulatory queries.
/li liHigh attention to detail and strong organisational skills.
/li liWillingness to undertake occasional travel for customer meetings, supplier visits, audits, or internal workshops.
/li /ul h3Our Offer /h3 ul liSalary range: €40,000 – €45,000 /li /ul pThe 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.
/p pBrenntag 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.
/p pWe welcome applications from women, men and non?binary candidates of all ethnicities and socio?economic backgrounds.
/p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7cyw3l