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Choosing the Right Regulatory Career: An Inside Look

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"Choosing the Right Regulatory Career" looks at the wide range of opportunities available to those interested in the regulatory profession.

The 21 authors, all experienced regulatory professionals, discuss the role of the regulatory professional in a variety of settings including large and small prescription drug companies, generic pharmaceutical companies, medical device and IVD manufacturers, Institutional Review Boards and consultancies, as well as specialties such as CMC, regulatory intelligence, promotional regulatory and medical writing.

The experienced authors also reflect on the paths they took into the regulatory profession.

The following is excerpted from Choosing the Right Regulatory Career, copyright © 2011 Regulatory Affairs Professionals Society.

Chapter 17. Your Career as a Biopharmaceutical Regulatory Writer

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.

What do Regulatory Writers Write?

Regulatory writers in the biopharmaceutical industry create documents, such as protocols and data summaries, for submission to regulatory agencies in support of drug development. Specifically, they create documents compliant with the requirements of the Common Technical Document (CTD), a set of specifications governing applications in support of new medicinal products. The CTD was developed by the International Conference on Harmonisation (ICH). Consisting of representatives from three regions,—the US, the EU and Japan—ICH develops common standards and practices related to the process of drug development and registration. Such practices are intended to “reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.” ICH developed the CTD in order to decrease the time and resources needed to compile and review a drug application as well as to simplify the exchange of information among regulatory authorities.¹ The CTD, particularly now that is usually submitted electronically (an “eCTD”), has become the raison d’être for regulatory writers.

Who Are Regulatory Writers?

Regulatory writers come from a variety of backgrounds. Currently, no clearly defined degree or certification is required for someone to be hired as a regulatory writer. However, almost all those employed in the industry hold at least a bachelor’s degree; very often, they have an advanced degree, such as a master’s or doctorate, or a professional degree such as an RN, JD, MD or PharmD. While many regulatory writers have scientific backgrounds, a significant number with liberal arts training are highly successful regulatory writers. Regardless of their education and background, successful regulatory writers understand the process of drug development and are thoroughly conversant with the CTD structure and guidelines.

The Fundamentals—Understanding Drug Development and the CTD

Drug Development in a Nutshell

A regulatory writer needs to understand enough about drug development to determine which documents need to be written. The decision to create a particular document is based upon the drug’s stage of development and the region of the world in which that document will be submitted. The goal of research in the biopharmaceutical industry is to bring to market a product that fulfills an unmet medical need. A pharmaceutical or biotechnology company that sponsors the development of a drug (the sponsor) must determine whether that drug will be a viable medicinal therapy. That is, the sponsor must find out whether that drug is effective in a certain indication (disease or condition, such as asthma or obesity) and whether the benefits of that drug outweigh its risks—often called adverse effects. The sponsor first tests the drug in vitro—“in glass”— and then in vivo—in animals, usually mice, rats, dogs, rabbits and sometimes monkeys and other primates. If data from these investigations are encouraging, a US sponsor submits an application known as an Investigational New Drug Application (IND) to FDA. Technically, the IND is a formal request to ship the drug across state lines; in fact, the IND is a petition to test the drug in human subjects. After review of the application, FDA will authorize studies of the drug in human subjects if it believes that participation in these studies does not expose subjects to unreasonable risks. An independent ethics committee also reviews the clinical study protocol associated with the IND for the same reason. In the US, this group is called an institutional review board (IRB); in Europe and many other regions of the world, it is known as an ethics committee (EC).

Investigations of a new drug intended for use in human subjects consist of three phases of clinical trials. If data from these trials are encouraging, a US sponsor submits a formal application, known as a New Drug Application (NDA), to FDA asking that the drug be approved for marketing and sales. If the drug is a vaccine or a blood product, the sponsor submits a Biological License Application (BLA). If, after review, FDA deems the drug to be effective and safe when used as directed, it will approve the drug for marketing. Very likely, it will require the sponsor to conduct more studies in human subjects in order to determine how the drug affects large segments of the population.

Submitting a drug application such as an IND, NDA or BLA (also known as the “dossier,” the “filing” and the “submission”) is a mandatory process for any sponsor who wants to sell and market a drug in the US. The application must be based on the CTD described earlier. The process of compiling a CTD-compliant application is time consuming and labor intensive. More often than not, the scientists and clinicians who have worked to develop a drug do not have the time, resources or skills to write the individual documents contained in any of these applications. Thus, the stage is set for the regulatory writer. A writer who understands the regulations governing both drug development and the CTD—the basis of the IND, NDA or BLA—and who has the skills and dedication necessary to create these documents becomes an invaluable partner to those in the field of drug development.