Case studies: Regulatory affairs officer: Hugo

Hugo is a regulatory affairs advisor in a pharmaceuticals company and he did a degree in biochemistry. This is his second role, both of which were obtained through a recruitment agency.

The key skills I got throughout my degree were understanding the biochemical pathways and how they are affected in different ways for different disease areas, and also the role played by medicines at the molecular level. Although my degree was relevant, only a general scientific understanding is required for this role, which can be developed in certain areas, should there be a wish to move into a specific field of regulatory affairs.

I entered into the profession as I had a desire to work in a pharmaceutical environment that would give me a broad picture of all stages of drug development, from selection of therapeutic targets to delivering medicines to patients. In my opinion, a pragmatic and analytical approach is required, with a high attention to detail and the ability to communicate well in both written and verbal situations.

Since starting this role, I have been given more responsibility and gained confidence through greater awareness of the applicable regulations. On a day-to-day basis, I prepare and submit dossiers to the relevant authority, covering all aspects of product licence management and clinical trial authorisation, such as the addition of new safety wording on product labelling, or changing the registered specification that products are tested against to ensure quality.

My other duties include the approval of promotional material for use by sales representatives to ensure code of conduct compliance, and reviewing company safety information to assess the need to update local labelling and prescribing information.

I enjoy the interaction with many different departments and roles, from marketing to the Qualified Person (QP). I also like having to communicate clearly and concisely with relevant Boards of Health to ensure a successful product lifecycle. The only downside is the checking required, and reference to pertinent regulations, which for some can become slightly onerous.

In the future I would like to continue to progress up the ranks, each time taking more responsibilities and perhaps getting opportunities to work on regulatory submissions/projects with increasing significance to the business.