., original/supplemental approvals, expedited program designations), and health authority engagements (e.g., FDA, EMA...
all regulatory documents meet regulatory requirements and guidelines (e.g., FDA, EMA) and company standards Stay...
regulations, including to the FDA, EMA, MHRA, and all assigned international RAs Implement pharmacovigilance SOPs and ensure the..., and other countries' Regulatory reviews;experience in US, EU Canada, Brazil, Australia preferred Direct FDA and EMA...
statisticians. Has led phase 1 and phase 2 oncology studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development...
studies. Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical...
contributing to drug applications with the FDA and EMA. Experience with applications in Japan and China a plus Able to collaborate...
documents with the FDA and/or the EMA....
, familiarity with ICH, FDA, and EMA guidelines Representing the biostatistics function, proactively collaborate with internal...
. Knowledge of regulatory requirements and standards (e.g., Data Integrity, GxP, FDA, EMA) related to laboratory operations...
of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g. FDA, EMA, MHRA, etc.). Possess...