Sentences with phrase «drug regulatory affairs»

Not exact matches

Serving as liaisons between the government and drug developers, regulatory affairs specialists play a key role in getting drugs to market.

«We approached this problem many years ago and have seen all kinds of studies, and there isn't anything definitive to say that antibiotics in livestock cause harm to people,» says Richard Carnevale, vice president of regulatory and scientific affairs at the Animal Health Institute, which represents the manufacturers of animal drugs, including those for livestock.

The programs focus narrowly on such areas as management of drug development, reimbursement affairs, and regulatory affairs.

When it comes to meeting Food and Drug Administration (FDA) requirements for their products, pharmaceutical, biologics, and medical device manufacturers are often challenged to maintain in - house staff with sufficient expertise in regulatory affairs.

Some options I'm familiar with are regulatory affairs and Food and Drug Administration (FDA) reviewer, but I would like to know what other career options are available that offer a top salary.

Focus on courses that provide you with broadly applicable tools: information technology, informatics, drug development, clinical trials, medicinal chemistry, operations management, and regulatory affairs are obvious choices.

Doctorate degrees aren't required for most positions, but knowledge of regulatory affairs, quality assurance, drug development, or clinical trials may be very useful.

It is also the regulatory affairs associate's responsibility to apply for a marketing licence for the new drug once it has been reached the appropriate phase.

Cafferty, who recently joined BIOCOM from another workforce development organization, also points to the UC Berkeley Extension, which offers courses covering bioinformatics, drug discovery and development, regulatory affairs, biotech manufacturing, quality assurance, and quality control.

Adams is responsible for the full spectrum of Infinity's drug discovery, preclinical, and clinical development strategy, and regulatory affairs activities.

In the regulatory affairs arena, her group provides the necessary documentation to the U.S. Food and Drug Administration for review and approval of IDRI's vaccine and adjuvant candidates in human clinical trials.

Before joining EVI, Hilde worked as a Senior Regulatory Affairs Consultant for European Drug Regulatory Affairs Consulting (EUDRAC) GmbH, prior to which she was from 2006 - 2013 in the global regulatory department of GlaxoSmithKline Biologicals (GSK) in Belgium, Thrombogenics, in Belgium and RSR Ltd., a diagnostic company in Cardiff, Wales.

SOURCES: May 4, 2010, press teleconference with Margaret A. Hamburg, M.D., commissioner, Michael A. Chappell, acting associate commissioner for regulatory affairs, and Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research, all with the U.S. Food and Drug Administration

This will be especially important if you're applying for work in regulatory affairs, quality assurance or drug safety.

«Gaining FDA approval for new drug and biologics licence applications [NDAs and BLAs] is becoming increasingly difficult and, in turn, there is an increased need for skilled regulatory affairs professionals, who can overcome such obstacles by developing innovative regulatory pathways to achieve market approval.»

The US FDA (Food and Drug Administration) is making companies jump through more hoops to secure drug approval, which is why candidates with skills in biometrics and regulatory affairs are in such high demDrug Administration) is making companies jump through more hoops to secure drug approval, which is why candidates with skills in biometrics and regulatory affairs are in such high demdrug approval, which is why candidates with skills in biometrics and regulatory affairs are in such high demand.

Roles are emerging in areas such as post-approval regulatory affairs for high volume off - patent drugs and development of biosimilars.

Position Overview A regulatory affairs associate is usually hired by a pharmaceutical company, to ensure that all of its products (including drugs and equipment) meet legislative requirements.

To excel in Quality Assurance and International Drug Regulatory Affairs Documentation for regulatory compliance in a pharmaceutical industry.

Tags for this Online Resume: Documentation, Management, Regulatory Affairs, Compliance, Integrate, Outsourcing, Quality, Risk Management, Triage, Audit, pharmaceutical, regulatory, Drug safety, clinical trials, research

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