About This Role
This specialist role supports the EMEA division on all regulatory, quality, compliance, legal, and product stewardship topics for a large portfolio of raw materials supplied to the pharmaceutical industry. The primary responsibility is to provide accurate, timely, and audit-ready documentation to pharmaceutical customers and support regulatory deliverables for bespoke product projects.
Responsibilities
- Prepare, review, and issue technical and regulatory documentation required by pharmaceutical customers, including Quality & Technical Agreements, Supply Chain Statements, Regulatory Questionnaires, and 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)
- 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
- Log, track, and report customer documentation requests using defined KPIs
- Support continuous improvement by identifying trends, gaps, and opportunities to streamline documentation processes
- 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
- 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
- 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
- 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
- Perform any other tasks within capability to support the commercial, regulatory, and compliance success of the Pharma business unit
Requirements
- 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
