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Online Resumes with "Regulatory Submissions "
Contract Medical Writer
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...
Tags for this Online Resume: Business Development, Cancer, Clinical Research, Medical Writer, regulatory science, biologics, drugs, medical device
Analytical chemist - 15+ years eperience HPLC, LCMS; pharma-biotech
HPLC and LCMS method development and validation in support of small molecule drug discovery programs, reglatory submissions, or related area
Tags for this Online Resume: HPLC and UHPLC, LCMS and LCMS/MS, analytical chemistry, method development and validation, cGMP and GLP, regulatory submissions
Biostatatician
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...
Tags for this Online Resume: Documentation, Medical, Medical Affairs, Publications, Due Diligence, Outsourcing, Pharmaceutical Industry, Process Improvement, Product Development, Protocol
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
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
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...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
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
Clinical Quality Assurance - 0 Years of Experience
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...
Tags for this Online Resume: Quality, Quality Assurance, Management, Test, Consulting, Engineering, Pharmaceutical, Protocol, QA/QC, Acquired Immune Deficiency Syndrome (AIDS)
Sr. Global Regulatory Assocate
Looking for a Regulatory Position in San Diego, CA area (or remote). Planning a permanent move from Philadelphia to San Diego, CA!!!
Tags for this Online Resume: Regulatory Affairs, Regulatory Publishing, Regulatory Submissions, Drug Safety, Clinical Safety, eCTD
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology
Biochemist/Quality Manager
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...
Ideal Companies: Abbott, Medtronics, Boston Scientific
Tags for this Online Resume: Beta Testing, Filing, Quality Assurance, Audit, research scientist hematology
