About This Role
This role involves supporting the EMEA Pharma Business Unit in regulatory, quality, compliance, legal, and product stewardship for raw materials supplied to the pharmaceutical industry. The Regulatory Affairs Specialist will provide accurate, timely, and audit-ready documentation to pharmaceutical customers and manage 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 fulfill 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 customized 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, harmonization 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
