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Online Resumes with "NDA approval"



Vice-President Regulatory Affairs

To oversee regulatory affairs, write and/or review all documentation required by regulatory authorities for the conduct of clinical trials and for NDA approvals. To provide regulatory guidance and stratagies.

Tags for this Online Resume: regulatory affairs, QA/QC, clinical, management

Featured Profile

Clinical Research - 20 Years of Experience - Near 33406

• Clinical Research Consultant with over 28 years of Pharmaceutical/Biotech experience including Phase I – III clinical trial development with direct involvement in multiple FDA/ICH submissions leading to six NDA approvals. • Extensive monitoring domestically and internationally, training and mentoring innumerable CRAs/Monitors in the field which lead to further training responsibilities with Study Teams and Management Te...

Tags for this Online Resume: Florida, Pharmaceutical Research, Monitoring, Management, Team Building

Life Scientist - 20 Years of Experience - Near 19335

Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval for a respiratory biologic and successful IND submissions. Extensive and broad based expertise in conceptualizing and desig...

Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices, oncology, protocol, pharmaceutical, ich, nonclinical, Regulatory Affairs, Quality Assurance, GXP

Life Scientist - 20 Years of Experience - Near 19335

Summary An experienced toxicologist with a successful track record supporting drug discovery research and development to progress biologic-based and/or small molecule drug candidate (s) through all phases of nonclinical development (Phase 1-4). Multiple successful NDA approvals, along with BLA approval and successful IND submissions. Extensive and broad based expertise in conceptualizing and designing nonclinical developmen...

Tags for this Online Resume: Audit, Research, Test, Toxicology, Protocol, Compliance, Training, Evaluate, Medical, Medical Devices