global construction consultancy renowned for delivering high-profile, complex and iconic large-scale capital projects..., and regulatory readiness tasks. Integration Across Workstreams Integrate engineering, procurement, construction, automation...
on an active construction site with heavy equipment and machinery. About the Company Our client is a leading global.... Integration Across Workstreams Integrate engineering, procurement, construction, automation, and CQV milestones. Track FAT/SAT...
will partner within the Global External Manufacturing (GEM) team to co-lead the process for the selection of CDMOs. The Associate... Director will also serve as the lead for contract negotiations for global CDMOs in partnership with the business units. Key...
, timelines, and resource allocation Strong understanding of global regulatory expectations and agencies such as FDA and EMA... Committee members as required Compliance and Safety: Ensure all projects and related tasks comply with Takeda global...
) are validated and maintained in compliance with FDA, EMA, and other global regulatory standards. This role involves close... Sciences, Computer Science, Engineering, or related field. 3–5+ years of experience in CSV within the biotechnology...
expertise: Strong understanding of global regulatory submission processes (e.g., FDA, EMA, PMDA) and compliance requirements... (AI) solutions to support global regulatory activities. This role sits at the intersection of data science, regulatory affairs...
of global CMC regulatory requirements for gene therapy products, including ICH guidelines (Q5A–Q14), FDA CBER guidance, EMA... stakeholders, will develop and execute global CMC regulatory strategies, author and review CMC sections of regulatory submissions...
applications. Ability to organize and present information clearly. Education and Experience BS in Engineering or Science... in a quality assurance-related discipline preferred. In-depth knowledge of regulatory guidelines (FDA, EMA, USP, EP, JP...
and remote/global teams. Responsibilities: 1. Business Development & Pre-Sales Opportunity Creation & Client Engagement Act... assessments. Ensure alignment with GxP, data integrity guidelines, FDA, EMA, WHO, and ICH expectations. Provide technical QA...
(model validation, explainability, bias monitoring). Ensure compliance with regulatory requirements (FDA, EMA, GAMP5, CSA... Management, Digital Transformation, or Engineering Program Delivery. 3+ years leading AI/ML or advanced analytics initiatives...