Regulatory Affair Specialist - Pharma

Airbus; Anagni; In loco; EUR 40.000 - 45.000; Tempo pieno

Descrizione del lavoro

Brenntag is seeking a Regulatory Affairs Specialist with a technical background in pharmaceutical or related industries. The role involves managing all regulatory aspects of the pharma business across the EMEA region, producing audit-ready documentation, and supporting regulatory deliverables for bespoke projects.

Office-based with occasional travel. The successful candidate will collaborate with QHSE, supplier partners, and commercial teams to ensure regulatory compliance and adherence to

Competenze

• Degree in a life science discipline or equivalent.
• Strong knowledge of pharmaceutical industry requirements for APIs, excipients, and raw materials.
• Understanding of European National Competent Authority requirements for distribution of APIs and materials.

Mansioni

• Prepare, review, and issue technical and regulatory documentation for pharmaceutical customers, including QA/tech agreements, supply chain statements, regulatory questionnaires and compliance statements.
• Ensure documentation is accurate, consistent and aligned with pharmacopoeia, IPEC guidelines, EU GDP and GMP guidelines.
• Gather regulatory, quality, and technical information; evaluate supplier documentation for completeness and suitability for pharmaceutical use.
• Log, track, and report customer documentation requests using defined KPIs.
• Lead regulatory deliverables for customer-specific projects and coordinate regulatory assessments for new products or customised specs.
• Support implementation of new regulatory requirements and internal standards across the business unit.
• Deliver training on regulatory topics and act as a subject matter expert on documentation and compliance.

Conoscenze

Fluent in English

Fluent in Italian

Strong written communication

Attention to detail

Collaborative

Formazione

Life science degree

Descrizione del lavoro

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.

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