the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence... and work instructions Understanding of the drug development lifecycle Experience working in a Global Regulatory Affairs...
the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence... and work instructions Understanding of the drug development lifecycle Experience working in a Global Regulatory Affairs...
the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence... and work instructions Understanding of the drug development lifecycle Experience working in a Global Regulatory Affairs...
/Authoring in the submission/CTD document space Understanding of the Common Technical Document (CTD), Regulatory Affairs... while transforming your career. Senior Manager Information Systems - Analysis and Delivery COE What you will do Let’s do this. Let...
in regulatory affairs. The Senior Manager will also be responsible for helping to deliver continuous improvement to enterprise..., and adaptability within an Agile work environment. Experience with regulatory documents in Regulatory Affairs, Research, Development...
you will support the Global Regulatory Affairs and Strategy organization in the constant pursuit of Execution Excellence. The Senior... to 18 years of related experience Experience working in a Global Regulatory Affairs organization Preferred...
to acquire rights 5. Collaborate with cross-functional teams, including R&D, regulatory affairs, legal, and commercial... to market strategy for all DRL Markets (PSAI+GG); IP; Lifecycle Management; Capacity; development; regulatory strategy o Define...
management, regulatory affairs, and people management. Roles & Responsibilities: Manage various Clinical Trial and Marketing... offices, external partners and regulatory authorities within the International (non-Americas) context. This role leads the...
offices, external partners and regulatory authorities within the North American context. This role leads the creation... of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing...
you will have a strong background in data management, regulatory affairs, and people management. Roles & Responsibilities: Provide support through... timely updates to the Regulatory Submissions and Document Information Management System, as necessary Manage requests...
deliver Amgen’s strategic approach towards Regulatory Affairs analytics, Data Standards and emerging Data Standard compliance... of IDMP, Regulatory Affairs business complexity and process interdependencies Experience with regulatory master data...
, in particular, International Regulatory Affairs teams. Demonstrating internal and external resources to support optimised submission... shape and implement the strategic framework for regulatory submissions across the Americas markets. The role involves...
teams, in particular, International Regulatory Affairs teams. Demonstrating internal and external resources to support... shape and execute the strategic framework for regulatory submissions across International (ex-Americas) markets. The role...
regulations, ICH and EMA guidelines/directives. Working knowledge of regulatory affairs. Works independently and with minimal... navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities...
in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties... standards. 6) Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs...
and comprehensive programs that elevate technical expertise for key roles in Research, Global Regulatory Affairs and Safety, Global... and comprehensive programs that elevate technical expertise for key roles in Research, Global Regulatory Affairs and Safety, Global...
for key roles in Research, Global Regulatory Affairs and Safety, Global Development, and Global Medical Affairs Works... expertise for key roles in Research, Global Regulatory Affairs and Safety, Global Development, and Global Medical Affairs...
, ICH) Understanding of the Common Technical Document (CTD), Regulatory Affairs and submission filings and related technologies in the... world. In this vital role you will play a key role in a regulatory submission content automation initiative...
Document (CTD), Regulatory Affairs and submission filings and related technologies Soft Skills: Excellent analytical... in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission process...
) Understanding of the Common Technical Document (CTD), Regulatory Affairs and submission filings and related technologies in the... role in a regulatory submission content automation initiative which will modernize and digitize the regulatory submission...