Pharma Regulatory Affairs Specialist: Documentation Expert

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 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