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... projects/initiatives, protocol development, PRO development, regulatory documents, scientific publications, and independent ... support of HTA advice and submission needs (10 countries annually) and ... He/She will have multiple cross-collaborative..
... Interface Management lead, responsible for regulatory compliance and inspection readiness for ... expert in product modalities, applicable regulatory intelligence and the application of ... ensure all local and global..
... global leadership role in the Regulatory Affairs department for the Chemistry, ... and Controls (CMC) aspects of regulatory documents and submissions. Responsible for ... and submissions. Responsible for multiple..
... development activities including preparation of regulatory submissions for the target clinical ... CRO management, clinical support of regulatory interaction, and study analysis and ... and reporting). Partner with Research,..
... Purpose and Scope: The Data Manager (DM) acts as the Astellas ... deviations and communicates to functional manager. Ability to identify data trends ... populations. Quantitative Dimensions: The Data..
... development and successful execution of regulatory strategies, plans and processes for ... region. Responsible to be a regulatory lead, which may include Global ... lead, which may include Global..
... products, including leading Global TA project teams as a pharmacovigilance specialist, ... Global TA. Leads Global TA project teams for assigned products, co-chairs ... marketed products, the development and..
... This role will handle all regulatory submissions related to Xtandi capsules ... strategic planning and execution of regulatory activities for development, registration and ... the generation and completion of..
... applying knowledge of Therapeutic Area, regulatory science, and signal surveillance to ... AOSE reports for IND SUSAR submission to the FDA. Ensure the ... data. If requested, support the..
... marketed products, the development and submission of the Risk Management Plan ... inspection/audit preparation, timely execution and submission of responses to findings and ... and for timely planning, creation,..
... Ensuring DHT operational excellence, global regulatory compliance and technology vendor oversight. ... solutions function, to support the submission strategy for the compound. Has ... to ensure quality, traceability, and..
... Clinical Development, Clinical Science, Research, Regulatory Affairs, Biometrics, and Quality Assurance. ... and manuscripts) and documentation for submission to regulatory agencies (IND, BLA). Develop and ... counterparts in Early..
... TA Heads, CMT Leads, Development, Regulatory Affairs, and Market Access. Essential ... projects, data interpretation, protocol development, regulatory documents, scientific publications, and independent ... will have multiple cross-functional collaborative..
... on an early to late-phase project. Serves as global medical lead ... medical lead (GML) on early-stage project or at the indication study ... medical program resulting in quality..
... and Scope: The Senior Biostatistics Manager supports a statistics lead on ... other key deliverables within that project - and/or he/she acts as ... for local projects or global..
... This includes the establishment of regulatory agency inspection and customer audit ... understanding of the QMS and regulatory compliance requirements. Evaluates inspection findings ... knowledge of applicable legal and..
