A peak behind the QbD screens: what does a Regulatory Affairs expert do?

In regulated industries such as the pharma industry, ATMPs, medical devices, biotechnology and cosmetics, the role of  Regulatory Affairs expert (RA) is indispensable. Whether it’s marketing a new product or introducing an existing product in new markets: an RA expert makes sure the products in question comply with all applicable laws, regulations and guidelines. Isabel Helena de Brito Manique is an expert in these matters. For 26 years she has been working as a pharmaceutical consultant and RA expert, the last three of which for Quality by Design. “In my role as an RA expert I can truly make a difference.”

Young and dynamic atmosphere 

Some six or seven years ago Isabel was introduced to QbD during a job interview. Even though no position was available at the time the interview did make an impression. “The young and dynamic atmosphere appealed to me, as did the link with the world of science. I like the mentality at QbD, it’s a highly instructive environment with enough opportunities for personal development.” A few years later it was time for the next step in her career and Isabel eventually did end up with QbD. As senior project manager her first project under the QbD flag involved value stream management and the regulatory affairs concerning the market authorisation of several pharmaceutical products. 

Validation protocols and risk analyses

Meanwhile Isabel works for several clients. “I work for several clients at the same time, both on short-term and long-term projects. My activities are very varied. I spend a lot of time writing technical documentation, for instance documentation to be filed with the American Food and Drug Administration for the marketing of new drugs. In doing so I have to take account of the applicable laws and regulations such as the Medical Devices Regulation (MDR). This legislation was supposed to replace the existing Medical Devices Directive (MDD) in May of 2020 but this has been postponed by one year. In connection to COVID-19 I am currently reviewing the regulatory affairs regarding face masks. This entails the preparation of validation protocols and determining which Good Manufacturing Practices (GMPs) must be applied. I also often work with risk analyses e.g. in case of ISO 14000 standards or HACCP certification. And finally, I also make quick scans and small audits, I am present when they are implemented and I am in frequent contact with notified bodies. These are official bodies appointed by an EU country to assess the conformity of products before they go to market.” 

A well-structured job 

Planning is crucial for an RA expert because many activities have tight timelines. What does an average working week look like for Isabel? “For every project I draw up a planning and a road map. What ISO guidelines must I go through? What guidelines do I have to set up? For what countries or regions do I have to map out existing legislation? Some countries are more accessible than others when it comes to marketing new products. And sometimes there are major changes, for instance as a consequence of Brexit. Every Monday morning I sit down with my coach and based on this meeting I adjust my planning. Right now I’m making an assessment for the validation of a software tool and then I’ll get to work writing a clinical validation protocol for a cleanroom. If urgent matters arise I handle them with priority but all in all it’s a well-structured job.”

Making an impact

It’s clear that Isabel loves her job. “I really love my job. Although I have to read and write a lot, which means I often work alone, I have a lot of contact with my QbD colleagues for different projects and with other departments at my clients, such as the legal department. For me, the best part of my job is the impact I have. As an RA expert I have a say in whether or not a product is released for market and in what form. If I assign a certain risk classification to a product then it will go to market with a certain label. And if I don’t do my job properly a product may be recalled following an audit. A huge responsibility, in other words.”

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