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Online Resumes with "Regulatory submissions"

In House CRA - 16 Years of Experience - Near 07645

To find a position in which I can effectively utilize my fifteen years of pharmaceutical/biotech knowledge within clinical and clinical oncology, generic drug manufacturing, Regulatory submissions and biotech coordination of IP shipments, tracking of worldwide shipments, usage of all Microsoft software as well as IVRS, CTMS, EDC, Documentum. I have a very diverse background in the industry, can contribute and share my know...



Tags for this Online Resume: Regulatory submission, CMC, cGMP, Compliance, Regulations and Guideline, US FDA, medical device, IND/NDA/ANDA

Agricultural Technician

I am looking for an opportunity to utilize all my skills in a leadership position and be part of a company that gets safe and effective products to patients in the safest, most reproducible, reliable and cost-effective manner. Having been at one company for so many years has allowed me the opportunity to go through many business growth phases. I was there when it was less than 100 employees to up to 300, then in 2002 w...

Tags for this Online Resume: Regulatory, Regenerative medicine, biologics, Project Management, biomaterials, biotechnology, Medical Devices, In vitro diagnostic devices

Featured Profile


Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...

Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)

Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor

Featured Profile

Physician with 17 years experience in Clinical Development, Medical Affairs, Communication collaterals, Regulatory Submissions and Stakeholder and Risk Management, Consulting to the Pharmaceutical and Medical Device Industries.

I am looking for Consulting opportunities where i can apply my logical and scientific approach to finding solutions to complex problems within the confines of regulation. I thrive when I am working with likeminded passionate team players who value my strategic planning, attention to detail and ability to identify potential problems and mitigate against them early on. I have 7 years therapy experience in Oncology where I l...

Ideal Companies: Janssen, Merck, TEVA, Smaller Pharmaceutical Companies who are in a period of growth or perilaunch where I would be able to do Medical Affairs for them, Medical Device companies

Tags for this Online Resume: Medical Affairs, Clinical Development, Phase 1-4 clinical studies, Pharmacovigilance, Due Dilligence, Launch, KOL management, Risk Evaluation Mitigation strategy

Clinical Regulatory Affairs - 13 Years of Experience - Near 19711

My background includes 13 years’ experience in the Pharmaceutical Industry at AstraZeneca Pharmaceuticals in Global Regulatory Submissions and Life Cycle Management of Regulatory documents. This includes 6 years’ experience as a Project Manager for Regulatory Global submissions. As a Project manager within the Submission Management Group, I provided expertise on global submission compilation and published electronic submiss...

Tags for this Online Resume: Newark, DE, Life Cycle Management, Regulatory Global Submissions, Pharmaceutical Industry, RSS Application, eCTD Publisher, electronic submissions, Regulatory Publisher, Management, Cardiovascular, Document Management, Legal, Pharmaceutical, Project Management, Publishing, Quality Assurance

Regulatory Submissions

Tags for this Online Resume: medical terminology, Documentum Data Base, ISI toolbox, Document Management

Clinical Research

Summary of Qualifications Clinical Research Manager, Associate, Monitor, Coordinator, with over 25 years experience in the medical field and 21 years experience in clinical trials with extensive experience in the fields of Cardiology, Electrophysiology, Neurology, Urology, Autoimmune, Respiratory, Gastroenterology, Weight Loss, Diabetes, Women's Studies, Arthritis, COPD, Gynecology, Endocrinology, Rheumatology and Stem Cell...

Tags for this Online Resume: Monitoring, Protocol, Cardiovascular, Clinical Research, Management, Pharmaceutical, Research, Therapy, Audit, Data Management, Medical Device, CRA, CTM, Clinical Trials

Featured Profile

Clinical Research - 1 Years of Experience - Near 35806

Professional Summary: Dynamic Clinical Research Scientist with five years of international research experience. Demonstrated expertise performing research feasibility, data collection and analysis, investigative procedures verification and report preparation. Proven medical knowledge of cardiology, nephrology, emergency medicine, intensive care, endocrinology, and gastroenterology. Skilled at researching diabetes and metabo...

Tags for this Online Resume: Clinical Research • Data Management • Statistics • Drug Safety • Clinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutical, gcp

Clinical Research - 8 Years of Experience - Near 85748

Initialized Managed stable and equine healthcare, trained jumpers, started young horses under saddle. training under saddle and exercised horses of various disciplines to include: jumpers dressage polo and racing. Prepped and exhibited thoroughbred yearlings for sales pavilion. Assisted in endoscopy exams and radiological soundness exams.

Tags for this Online Resume: Scottsdale, Clinical Research, Compliance, Clinical Research Coordinator (CRC), Device Trials, Documentation, Clinical Trial, Medication Trials, Data collection, Microsoft, Electronic Data Capture (EDC), Regulatory submission


COVER LETTER: Vanessa Nunes de Paiva, PhD Student Postdoc Research Associate Laboratory of Dean Tomas R. Guilarte, PhD Vanessa Nunes de Paiva, PhD Student Postdoc Research Associate Laboratory of Dean Tomas R. Guilarte, PhD Florida International University Departament of Enviromental & Health & Social Work Departament pf Environmental & Occupational Health 11200 SW 85th Street AHC 4, Room 340 Miami, FL 33199 Lab Phone: (305...

Tags for this Online Resume: ELISA, Email, Medical, Medical Affairs

Biomedical Engineer - 19 Years of Experience - Near 84092

Qualifications include: 19 years experience in medical device/pharma fields. 7 years experience in other industries including semiconductor mfg. and marine engineering. Team member of 3 successful medical device companies through start-up, acquisition and integration. Broad experience operating a medical device business to include: R&D, engineering, manufacturing, regulatory, QAQC, operations, finance, and sales and marketi...

Tags for this Online Resume: Medical Device, Emergency Medicine, Surgical, Engineering, Research and Development, Medical Devices, Regulatory, Qualify assurance, Manufacturing