CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "FDA EMA"

Regulatory Affairs Associate

Fulltime opportunity in Regulatory Affairs Function

Tags for this Online Resume: Regulatory Submission, ECTD, PDF Editor, SPL, Regulatory Compliance, Regulatory Compliance/FDA/EMA (EU), Clinical Trials, NDA/ANDA/IND/CTA, Medical Devices

Clinical Research Associate, Chicago, IL

I have been working in the Biotechnology industry for the last 9 years in the Pharmacokinetics & Drug Metabolism group at Amgen. I worked to characterize the pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PK/PD), and metabolic fate of novel drug candidates using state-of-the-art procedures and technologies. I supported discovery from research into the clinical. I developed and validated analytical methods whic...

Energetic, results-oriented individual with established credibility and respect at FDA and EMA. An extraordinary record which includes the lead and approval on New Drug Applications (NDA) and Marketing Authorization Application (MAA)

Global Regulatory Affairs leader for a combination of RA functions. Provides clear and specific regulatory input using skills(scientist, regulator and lawyer) to provide strategic planning decisions and implementation enabling successful drug approvals. Strong leader, expertise in DD, alignment with business goals, creative, proficient with complex frameworks and integration of abstract concepts in clinical and CMC areas o...

Tags for this Online Resume: Regulatory Affairs, small molecules, CDER, CBER, FDA, EMEA, IND, NDA, CTA, IMPD, proteins, anti-infectives, cardiovascular, pain, oncology, CMC, compliance, communicator, monoclonal antibodies , Biologics, Food and Drug, Global, eCTD, health authorities, alliance management, combination products, Biologics Biosimilars , Director , pharmaceutical , Leadership, Problem solving , Innovation, experienced, IND NDA CTA MAA, business goals , biologics - pharmaceutical , biosimilars

Biochemist

Tags for this Online Resume: Regulatory Affairs , FDA EMA, NDA MAA, Compliance , Clinical - CMC, Leadership, Experienced IND CTA, Proficient- Pragmatic , Innovation

Life Scientist - 20 Years of Experience - Near 80504

Seeking Senior Management level position in Quality Assurance, Quality Control or Validation.

Tags for this Online Resume: Validation, Microbiology, Aseptic processing, Method transfer, Method Development, FDA/EMA/JP, Regulatory Compliance host, API

Clinical Research - 20 Years of Experience - Near 60202

QUALIFICATIONS * Internist with 20+ years experience working in the the pharmaceutical industry including small, medium and large pharma, CRO and biotech in the USA, Canada, LatinAmerica, and Europe (including Eastern Europe), and Russia. * Board Certificatioon in Internal Medicine and training in Critical Care Medicine. Clinical practice experience in Hospitals, Emergency and Critical Care settings. * Extensive experience ...

Tags for this Online Resume: Project Leader, Executive Medical Director/VP, Protocol, Cancer, COPD, Critical Care - Respiratory, OTC, Clinical Programs, Research and Development, CardioVascular, Pain & Inflammation

Quality and Regulatory Compliance

SUMMARY Expert Quality and Regulatory Compliance Professional, experienced in global processes and systems that assure appropriate cGMP/Regulatory compliance levels are maintained at all times across geographical territories. Excellent understanding of the ever-changing regulatory environments and well-versed in requirements and mitigating risks. Drives resolution. Provides leadership, guidance and solutions to complex qual...

Tags for this Online Resume: CMOS, Health Care Industry, Integrate, Training, Documentation, Intensive Care, Document Review, Filing, Planning, Services

Pharmaceutical Scientist

SUMMARY * Scientific Leadership-Pharmaceutics. Wealth of experience (>25 years) in delivering impactful products to the market through Formulation/Process development (solids, liquids, and parenteral dosage forms) and Analytical development. Key example: Lexapro marketed by Forest. * Organizational Leadership and Mentor. Scientific organization management that focused on learning and delivering results. Underlying philosoph...

Tags for this Online Resume: Management, Business Development, Documentation, MOS, Pharmaceutical, Due Diligence, Manufacturing, Packaging, Process Improvement, Quality

Biologist - 7 Years of Experience - Near 91346

SUMMARY As a Quality Manager, my job is to ensure the quality of our product. Without controlling the quality of our product, there is no product. My skills and abilities are the following: strong knowledge of ISO, GMP, GDP, SOP, and GLP ~7 years of quality systems and quality oversight calibration of medical devices to ensure validation controlled temperature chambers (CTC) raw materials handling and testing ~5 years of ou...

Tags for this Online Resume: Inventory, Microbiology, Payroll, Chemistry, Media Preparation, Documentation, Quality Oversight, Quality Management, Supervise, FDA, GMP, EMA, GDP, Compliance, Raw Materials, Quality Assurance, Quality Control, Sampling, Audits, Biology, Human Factor VIII, QCA, Biotechnology, Pharmaceutical, GLP, ISO, CAPA

Quality Assurance Director - 11 Years of Experience - Near 07076

SUMMARY Detail oriented and results focused professional with experience working in a global pharmaceutical company, research and development with multiple manufacturing sites and regulatory authorities worldwide. Possess clinical education, drug development and strong analytical background and solid understanding of the ICH, FDA, EMA Regulatory Guidelines as well as other regulatory body's guidelines and CMC requirements t...

Tags for this Online Resume: Good Laboratory Practices, Microsoft, Microsoft PowerPoint, Microsoft Visio, Policies and Procedures, Protocol, Quality, Quality Assurance, Research, Research and Development

Army - 20 Years of Experience - Near 46143

SUMMARY Highly experienced Senior Quality Assurance Manager and Military Veteran with a Security Clearance and 20+ years of proven experience in supply chain management in the Department of Defense, public and private sectors. Possess extensive knowledge in General Management and Supervisor Operations as well as FDA, EMA, OECD and LGS Quality Systems Regulations. Expert in ensuring compliance, identifying and implementing q...

Tags for this Online Resume: Quality Assurance, Test, Customer Service, Quality, Quality Control, Defect Tracking, Help Desk, Information Technology, Manufacturing, Project Leader