Marketing authorisation related activities are a staple of any company with medicinal products in their portfolio. There is often someone with a title such as ‘Regulatory Expert’ to handle matters related to marketing authorisations. Their tasks may vary depending on whether they work at the head office or an affiliate, whether the company holds the marketing authorisation, or whether the company is a marketer and whether the products come from their own factory or from a contract manufacturer.
To give you some insight into my line of work, let me tell you about a day in the life of a consultant.
9 A.M. – I boot my computer at home. If there is nothing on the agenda right away, I have time for a quick walk outside with my son before we start work and school.
Our translators have finished working on product information for a client’s marketing authorisation application, soon to be submitted. I go through their notes and finalise the text. I deliver the application to the client, and it’s a wrap for now.
9:45 A.M. – Morning coffee with colleagues. Many of us like to sit down for an online meet-up on Teams and exchange views on this and that. I wonder what issues or titillating polling questions we’ll be tackling today…
10:15 A.M. – A client is having trouble with the availability of a certain medicine. I prepare an exemption application for foreign language packages. This an important application to ensure there are no interruptions to patients’ medicinal treatments.
I set up a virtual meeting with our Market Access team to discuss issues related to the reimbursement of the medicinal product. Cooperation and shared understanding between teams is very important for us so that we can serve our clients efficiently while maintaining a big picture
11 A.M. – Pharmaceutical wholesale team meeting. We discuss current issues related to quality management of medicines.
11:30 A.M – Lunch at the home office. Other colleagues working from home join in for some chit-chat.
12 P.M. – A client needs counsel on a variation application they’re preparing for Finland, Sweden, Denmark, and Norway. We set up a phone meeting and discuss the case.
12:30 P.M. – Client’s market authorisation requires several variation applications. I start preparing the applications. I fill out application forms and organise required appendices, check variation types, and send a small translation request to our excellent in-house translators.
2 P.M. – A quick catch-up with my manager. We discuss our current work situation and where we are with our bigger projects. The workload can vary quite a bit from day to day in this line of work, and that’s why it’s important to look at the big picture with the team and catch up on a regular basis.
2:15 P.M. – Time for a break and some exercise. I do some shoulder rolls and squats, get my shoulder blades moving. My body and my mind are refreshed. We’re also running an exercise bingo. We fill up our bingo cards as we exercise and compete for fun prizes.
2:30 P.M. – There is some interesting news on Fimea’s website that I want to share with my colleagues at DRA. I write a few words on the subject on our internal channel. Keeping up-to-date and sharing information is very important in our work, and it’s a part of my daily work.
2:45 P.M. – We have feedback from the Swedish authorities on a submitted variation application. I go through the comments and start thinking of possible responses. I put in an inquiry to our client who is quick to reply. We agree on what to do next and schedule a phone meeting for next week.
Ultimately, our work is about securing availability of efficient and safe medicine for patients.
Meanwhile, a colleague needs some input on a case. In our work community, it’s a huge advantage to always have a colleague available for brainstorming.
4:15 P.M. – I have more information from the client for the exemption application I started preparing this morning. I make a phone call to Fimea to double-check on a requirement, complete the application and e-mail it to the authorities for review.
4:45 P.M. – One more reply to a consultation request, and it’s a wrap for the day. It was another busy one. My expertise, collaboration skills, solution-oriented approach and big-picture thinking were again needed.