). Strong understanding of GMP/GxP requirements for large molecule commercial reagents as per global agency (e.g., FDA, EMA... will lead a multidisciplinary, global team (including first-line managers and scientists) and collaborate extensively...
knowledge of PV regulations: FDA (21 CFR 312.32, 314.80, FAERS), EMA GVP (Modules VI, VII, IX), and ICH E2 (E2A-E2F). Direct... (Big 4 or life sciences consultancies) in PV projects. Involvement in regulatory inspections (FDA/EMA GVP), and audit...
of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale... and safer. We provide our global teams with the resources needed to achieve individual career goals while helping...
relationships. Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business..., Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T...
About Servier With commercial stage products and a promising pipeline, we are Servier Group, a unique global... - MSAT, this global role leads a team of subject matter experts (SMEs) responsible for supporting commercialization...
Senior Engineering Technician Position Summary: Work Schedule: 7pm-7am, Sunday-Tuesday and every other Wednesday... 100% on-site Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development...
About the Team The AI Deployment Engineering team works at the intersection of cutting-edge AI research and real... a Manager, AI Deployment Engineering to lead our Healthcare & Life Sciences deployment efforts. In this role, you will build...
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...
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...
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...