A day as a regulatory affairs consultant for Nordic countries
Sipping on my first morning coffee, I’m curious about what kind of day is in store for me today. From the number of new e-mails, it looks like it is going to be a busy one with many different clients. A few things from earlier are still pending on my to-do list. I start by organizing my tasks based on their priority and proceed to review my first email of the day.
First on my list is a variation of a marketing authorization of one of my clients. It is about addition of new adverse event, requiring several references and supportive documentation, which I compile as an eCTD sequence for submission. I need to check the guidelines and regulations to make sure every document, such as updated product information and all references are enclosed, named, and organized in a correct manner. The success of my work is measured in technical validation. The sequence passes the validation, and I´m very glad that my careful pre-work is paying off.
Next, is a review of a common Nordic package. The component must be meticulously assessed, ensuring it adheres to the approved product information and regulatory requirements in the concerned Nordic countries. I notice a few small errors, so I´m returning the artwork with comments. After the revisions are made, it will be ready for submission. The cheerful chatter of a group of colleagues brings to my attention that it’s lunchtime.
After lunch, it is time to take on a translation task. The text is a Summary of Product Characteristics with quite extensive updates. Accuracy is of utmost importance, as errors or misunderstandings can have serious consequences for patient safety. Just to be sure that I have included all changes and translated the new texts correctly, I ask my colleague to do a quality check review.
Throughout the day, all sorts of questions arrive via e-mail. My clients often need help navigating the huge jungle of rules. There are questions on grouping of variations, submission timelines, national implementation timelines and regulatory fees. There are also questions on price notifications, product divestment and shortage notifications. As I navigate through the questions I´m reminded that it is soon the time to distribute the regulatory newsletter to my clients. I´m adding regulatory intelligence review to my tasks.
The grand finale of the day unfolds with the updating of the local product information databases. There are a few new text sections in this new product information. Soon the newest product information will be easily accessible for every doctor and patient.
Just as I´m about to finish for the day I see a new e-mail with a request for the review of commercial materials. I´ll answer my client that I will do the review in due time and add it on my to-do list.
Looking back on my day, I realize how many different things I did today. No two days are identical, and every day brings its own distinct experiences. Each task plays a part in the big picture of regulatory affairs. It’s like a symphony where creativity and following the rules come together, shaping the day of a regulatory affairs consultant.
