• Feature ArticlesFeature Articles

    Proving a Professional’s Regulatory Worth During Salary Negotiations

    Even if a person does not get what is deserved in life, a regulatory professional often has a better chance of getting what is deserved on the job if he or she can negotiate salary effectively. To evaluate worth to an employer, the regulatory professional must know him- or herself, the business ecosystem and his or her ability to deliver desired professional qualifications. Many employees do not negotiate their salaries. The reasons people shun negotiations include: fe...
  • Regulatory NewsRegulatory News

    FDA Quietly Announces Creation of New Regulatory Division, Search Begins for Leader

    The US Food and Drug Administration (FDA) is looking to hire a high-level regulatory official to lead the agency's brand new division of Regulatory Affairs Strategic Management (RASM), it announced this week. The position, for a deputy associate commissioner, was recently created "to respond to significant changes in the regulated industry" and FDA's scope of authority, the agency said in its job posting for the position. Explained FDA: "These changes includ...
  • Feature ArticlesFeature Articles

    Answering the Call for Excellence in Regulatory Education

    The regulatory landscape has evolved dramatically in the last few decades. Today’s regulatory professionals perform key functions in their organizations, including ensuring compliance with regulations and facilitating the development and commercialization of new products. These professionals must be equipped to address the increased complexity of the modern regulatory landscape. One important way to prepare is through graduate studies. Graduate education in regulatory pla...
  • RAPS' LatestRAPS' Latest

    Survey of Regulatory Pros Draws Increasingly Global Response

    RAPS' biennial research survey of the regulatory profession, launched at the end of January and continuing through Monday, 31 March, has garnered well over 2,000 responses to date, with 29% from outside the US. The Global Scope of Practice & Compensation Survey has been conducted by RAPS for nearly 25 years, and it continues to be the largest, most comprehensive study of the healthcare products regulatory profession. Increasingly, survey responses are coming from p...
  • Feature ArticlesFeature Articles

    Adding External Resources to Global Teams

    • 14 March 2014
    This article provides a perspective on the inclusion of regulatory consultants and contractors in global pharmaceutical product development and commercialization teams. For purposes of this article, external consultants are defined as individuals or firms with specialized knowledge or expertise in a particular field or region. Contractors are those that provide resources and/or regional knowledge. Consultants are able to fill knowledge and experience gaps in project teams...
  • Feature ArticlesFeature Articles

    First Years in a Regulatory Career

    "The people who get on in this world are the people who get up and look for the circumstances they want, and, if they can't find them, make them." --George Bernard Shaw Entering a new field is often a challenge, but knowing what to expect and how others have prepared for it can help. The best information comes from people who are right in the middle of the challenge. Therefore, as a professor in the University of Washington's Biomedical Regulatory Affairs Master's Progr...
  • RAPS' LatestRAPS' Latest

    RAPS Launches Global Survey of Regulatory Professionals

    • 28 January 2014
    RAPS today launched the 2014 Scope of Practice &Compensation Survey of the Regulatory Profession , a survey of professionals around the world-both RAPS members and nonmembers-who are involved with the regulatory process for healthcare products. The survey asks regulatory professionals working in the pharmaceutical, biotechnology and medical device industries; regulatory agencies; academia, consultancies and other settings about their jobs, backgrounds and compensati...
  • Feature ArticlesFeature Articles

    Looking to the Future in Regulatory Affairs

    Predicting the future is, of course, like gazing into a crystal ball; therefore, the reader is warned that the following is based in part on indicators from industry and the regulators, but mostly on personal considerations and expectations, and discussions with peers in the regulatory community. There are many strands to consider when looking to the future in regulatory affairs. The first strand is the regulations and how these are likely to be impacted by a globalized ...
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    New RAC Eligibility Requirements, Deadlines, Application Fees Coming in 2014

    The Regulatory Affairs Certification Board (RACB) has approved a number of changes to the policies governing Regulatory Affairs Certification (RAC) that will go into effect in 2014. The changes affect both those taking an RAC exam for certification and those who have already been certified and wish to maintain their RAC credential in good standing. New Eligibility Requirements The most significant change is to the eligibility requirements for candidates seeking the cre...
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    RAC-exam Prep Webcast Presenters Give Advice for RAC Exam Takers

    Passing the Regulatory Affairs Certification (RAC) exam can be a significant milestone in your regulatory career. The RAC is the only post-academic professional certification specifically for healthcare product regulatory professionals, and in the 22 years since it was first introduced, it has developed a reputation as a respected and important credential in the field. Why Get the RAC? While regulatory experience is almost certainly the most important factor employers...
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    Why Get Regulatory Affairs Certification? Ask Those Who Have It

    As a regulatory professional, you may be considering Regulatory Affairs Certification (RAC) as a way to distinguish yourself, demonstrate your regulatory knowledge and skills, advance your career or even as a tool to help you expand and sharpen your grasp of regulatory issues and critical thinking skills. After all, the RAC is the only post-academic professional certification specifically for healthcare product regulatory professionals. But what do those who have the cre...
  • Veterans Administration Announces Proposal for Drug Development Initiative

    • 29 November 2012
    The development of pharmaceutical products has typically been the purview of obvious agencies-The National Institutes of Health (NIH), which funds research; the US Food and Drug Administration (FDA), which oversees much of the research and approves products; and the Institute of Medicine (IOM), which provides recommendations about the nation's healthcare system. Now, you might want to add one more agency to that list: the Department of Veterans Affairs (VA). The agency,...