EU Service Delivery Lead and Line Manager for life sciences Regulatory Operations programs with responsibility and accountability for the success and growth of our people, our projects and our future business opportunities.Regulatory and CMC data SME with specific focus on creating connected and data-driven regulatory solutions to meet future regulatory requirements and enable systems interoperability, insights-driven decisions and automation.

Program Lead for life science regulatory programs delivering CMC regulatory dossiers and strategies to the pharmaceutical industry. Project areas include management, regulatory strategy and authoring of post-approval CMC dossiers for manufacturing site transfers, CMC gap analyses, CMC process redesign.

Responsible for: audit and QA approval of raw data, client reports, assay validation reports, site, facility and supplier audits; Management of non-conformances, root cause analysis, CAPA management; Supplier Management.

Responsible for authoring, delivering and securing approval of regulatory CMC dossiers for submission to Health Authorities, developing and influencing CMC regulatory strategies for clinical and late-stage pharmaceutical products, ensuring alignment between regulatory dossiers and manufacturing practices and advising R&D teams on regulatory requirements for manufacturing, testing and quality control.

Responsible for: designing and scaling up synthetic routes to active pharmaceutical ingredients and technical transfer to kilo lab, pilot plant and commercial manufacturing facilities and generating process understanding in support of commercial process validation including impurity profiling and purging and process parameter setting.