Under RAPS

14 May 2012

Next RAPS Virtual Career Fair: 17 May

By Zachary Brousseau

The Regulatory Affairs Professionals Society (RAPS) will host its next Virtual Career Fair on Thursday, 17 May, from 10 am–6 pm EDT. RAPS members can enter the fair at 9 am—one hour ahead of the [Read More...]

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17 February 2012

Choosing the Right Regulatory Career: An Inside Look

By Nancy R. Katz, PhD

One option for a career in regulatory affairs is becoming a regulatory writer in the biopharmaceutical industry. This profession is acknowledged as meaningful and challenging, and regulatory writers are recognized as vital to the industry. Regulatory writers are employed in biotechnology, pharmaceutical and medical device companies, as well as contract research organizations (CROs), and can be full‑time staff members or consultants to all of the above. This chapter describes the work of a regulatory writer in the field of drug research. It explains the fundamental knowledge required to perform the work and the specialized knowledge needed for success. Its focus is on submission of drug applications in the US. [Read More...]

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