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Online Resumes with "Regulatory submissions"
Summary Work Experience: Strong background in medical writing and biotechnology product and services development, with a solid publication record in the peer-reviewed medical literature in addition to biotechnology analyst articles-an unusual combination of medical writing expertise, analytical skills, data analysis, management experience, and medical knowledge. Participate in pre-clinical, clinical, and commercial research...
HPLC and LCMS method development and validation in support of small molecule drug discovery programs, reglatory submissions, or related area
Summary Highly skilled, results-oriented and a loyal Biostatistician with 15+ years of leadership experience. I have played vital roles in clinical development of and launches, or commercial marketing of medications in the realms of Cardiology, Anti-Infectives, Anti-bacterial, Ophthalmology, Immunology, Regenerative Medicine, CNS, Hematology and GHD. Phase 2B/3/4 clinical trials in varied therapeutic areas. Statistical lead...
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
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...
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Executive Profile Summary I have for over 25 years acquired a vast knowledge in cGMP, Quality Management Systems, and Quality & Compliance in the areas of Pharmaceutical / Biotechnology / Biologics / Chemical Product Development / Quality Assurance & Control, and Food and Chemical Industries (which includes Food & Consumer Goods), (Industrial Retail & General Manufacturing ). My detail-oriented critical thinking creative-pr...
Looking for a Regulatory Position in San Diego, CA area (or remote). Planning a permanent move from Philadelphia to San Diego, CA!!!
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
I am looking for a challenging position of increasing responsibility in Quality or Research and Development. Trained Biochemist/Molecular Biologist with over 22 years of experience, including 15 years of extensive research and drug development experience in Hematology/Oncology. This includes a diverse set of laboratory techniques and administrative skills. I have had positions of increased responsibility and I was a co...