• Feature ArticlesFeature Articles

    Value of an RA qualification in continuous professional development and career progression

    Continuous professional development (CPD) is important for employee personal development and is of strategic value for organizations. Having qualified and knowledgeable personnel can help deploy strategy and yield competitive advantage in the marketplace. This article presents the results of a qualitative and quantitative study on the progression and experiences of industry-based graduates who completed a masters in regulatory affairs. The results demonstrate that regulato...
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    The PhD scientist’s pathway into regulatory affairs

    Making a transition from a life and health science research scientist to a regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.   Intellectual curiosity is often the impetus for pursuing a doctorate degree (PhD). The desire to learn a su...
  • Feature ArticlesFeature Articles

    Good writing skills as a cornerstone for career advancement

    Strong written communication skills are invaluable, even in a profession in which writing is not a key component. Good writing can be used as a tool to impart information or convince colleagues to pursue a particular course of action. It can also be a means of demonstrating one’s creative and strategic thinking. In short, investing time in learning and refining strong writing skills is a crucial element of career advancement.   This article will provide tools and techn...
  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
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    Regulatory Career Progression

    This article discusses pathways for a career as a regulatory professional and possible career progression from junior to senior to managerial level. It summarizes the skills required for each level and what it takes to move up the corporate ladder. It also provides the responsibilities expected of a regulatory professional in a senior management position. Introduction A regulatory department is a significant part of any pharmaceutical company and regulatory profession...
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    RAPS Virtual Career Fair, 30 March, Connects Regulatory Job Seekers, Employers

    • 28 March 2017
    Regulatory professionals looking for new employment opportunities and employers seeking regulatory staff will have another opportunity to connect when RAPS hosts its next Virtual Career Fair this Thursday, 30 March, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs allow regulatory job seekers to explore openings and talk with employers in real time from anywhere in the world. Confirmed exhibitors for the 30 March fair are: Baxter International BD (B...
  • Regulatory NewsRegulatory News

    Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

    The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa. As part of the project, WHO, GlaxoSmithKline, the developer of the vaccine, and the nonprofit PATH will collaborate to donate doses of the vaccine candidate, known as RTS,S, for use in the WHO pilots. In addition to the Gavi funds, WHO will provide about $17 ...
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    Regulatory Job Seekers, Employers to Connect via RAPS Virtual Career Fair, 23 June

    RAPS will host its next Virtual Career Fair on Thursday, 23 June, from 12:00 to 4:00 pm EDT. RAPS’ Virtual Career Fairs are held regularly throughout the year. They are a convenient way for regulatory job seekers and employers looking to hire regulatory talent to connect online in real time. Prestige Brands is a confirmed exhibitor for the 23 June fair. Other employers who wish to participate can find out how to exhibit here . Participation in the event ...
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    RAPS DC-Baltimore Chapter to Host Career Day This Weekend

    The RAPS DC/Baltimore Chapter will once again host its Mid-Atlantic Career Day this Saturday, 21 May, on the Johns Hopkins University Montgomery County campus in Rockville, MD. This is the third year for the popular event, which in past years has drawn more than 100 attendees from all around the mid-Atlantic region and beyond. This year’s career day comes as the US Food and Drug Administration (FDA) is placing a strong emphasis on developing a strong FDA wo...
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    RAPS Chicago Chapter to Host 2nd Annual Midwest Career Day

    This Saturday, 7 May, the RAPS Chicago Chapter will host its second annual Midwest Regulatory Career Day . The event will go from 10 am to 3:30 pm at the Hilton Garden Inn in Mettawa, IL. Speakers will include regulatory professionals working in industry, consulting and the US Food and Drug Administration (FDA), as well as career experts and representatives from several respected regulatory and related academic programs. View the full program agenda online. ...
  • Regulatory NewsRegulatory News

    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...
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    RAPS to Host First Virtual Career Fair of 2016 This Week

    RAPS will host its first Virtual Career Fair of 2016 this week on Thursday, 11 February, from 12:00 to 4:30 pm EST. RAPS’ Virtual Career Fairs are held regularly online and provide a convenient venue for regulatory job seekers and recruiters to connect confidentially in real time. Confirmed exhibitors for the 11 February fair are: GlaxoSmithKline Adecco Globus Medical Participation in the event is free for job seekers, who may register using th...