After completing my chemistry degree, I decided I wanted to pursue a career in the pharmaceutical industry. Soon I joined a small Polish company in which over 3 years I was involved in some great projects at R&D lab where I gained work experience as a chemist as well as several life skills, organization, time management and communication all of which are highly required for regulatory affairs.
Since I have always had a flair for searching, discovering and opening seemingly closed doors in my R&D role I managed with the project aiming to develop a process of preparation of an anxiolytic active substance at lab scale and than transferred it from lab to production scale. This exposed me to regulatory CMC [Chemistry, Manufacturing and Controls] activities. The combination of chemistry, strategy and working with people greatly appealed to me, so I decided I wanted to move into a more direct regulatory affairs position. My work experience at R&D and the role I held, helped me secure my regulatory affairs training position. Within the next years I was working on numerous different projects in different areas of regulatory affairs and under the supervision of very experienced regulatory affairs professionals in different pharmaceutical companies. The learning curve was constantly seep, have had to familiarize myself to a professional world of writing and consulting regulatory documents, I provided up-to-date regulatory documentation at different level, gave advice regulatory strategy decision on CMC related changes.
My last position was at Fresenius Kabi Polska. As Department Regulatory Affairs Manager I excited working on many challenging projects and with fantastic team of people. The experience I gained within the time at Fresenius was endless however as I am constantly keen to broaden my horizons and further enhance my regulatory knowledge and also I enjoy working at regulatory affairs for a number of different clients I decided to come to move onto the next challenge and started acting as an independent consultant.
I invite my future Clients to contact me and talk.
