are required to be onsite. Responsibilities: Serve as a senior subject matter expert (SME) on U.S. FDA, EMA, and ICH-GCP regulations...
requirements from FDA, EMA, MHRA, and other established and emerging authorities - to effectively support GCP inspections worldwide.... May serve as point of contact for a specific regulatory area (e.g., FDA, EMA, NMPA). Is responsible for monitoring...
that meet both regulatory and company requirements. Maintains expertise on various regulations (FDA, EMA, ICH, etc.) Provides...
guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations...
inspections (e.g., FDA, EMA, MHRA, TGA) within a commercial GMP manufacturing facility, including defense of sterility assurance...
with FDA, EMA, and other regulatory standards and requirements required Advanced knowledge and application of cGMP's and ASME...
with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents. Proven experience...
relationships with key analysts and research firms such as Gartner, Forrester, IDC, EMA, and GigaOm, positioning Riverbed...
guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations...
requirements (FDA, EMA, etc.). You have proven technical leadership capabilities and demonstrated project management skills...