REGULATORY AFFAIRS / DRUGS / FOOD SUPPLEMENTS / MEDICAL DEVICES
Hello! I'm Miluše
I help companies to fulfill regulatory requirements of their products (medicinal products, medical devices, food supplements, food) in accordance with the Czech & EU legislation with the aim to facilitate the product´s launch. I act as the main contact person for communication with national Competent Authorities and ensuring compliance with the applicable requirements.
My professional experience allows me a leading global or local registration procedures. Also, compilation and assurance of a high standard of the registration dossier for new registration, variations and renewals is a key to keep compliance with the EU/local requirements.
I am also passionate about a healthy lifestyle which helps me working effectively and keep me fit :-).
ZENTIVA k.s., (Dossier Management Department)
S&D Pharma CZ, (Local Regulatory Affairs)
I get the experience with the collection and coordination of regulatory documents for submission of new registrations/variations/renewals (DCP/MRP/National procedures) in EU & CIS & Emerging markets. I was mainly responsible for the lifecycle of my own portfolio of generic products, preparation of dossier, eCTD compilation.
XANTIS PHARMA CZ, (Global Regulatory Affairs)
ARRIELLO s.r.o.,(Global Regulatory Affairs)
I was mainly responsible for the active management of individual procedures such as new registrations, renewals, variations, withdrawals ensuring the registration procedures are approved in a timely matter. I also communicated with Authorities and coordinate the whole project with our commercial partners.
I am mainly responsible for leading regulatory procedures (new registrations, variations, renewals) of my clients. To provide regulatory advice in terms of RA strategy, LoD, Marketing advertise approval, e-CTD compilation, preparation of package information..etc.
I pay attention that my clients/partners always know WHAT am I doing and WHY I am doing it. I also keep them updated about the progress of assigned tasks.
I respect my client´s needs and take care that he gets what he asks for. I accept assignments for which I can provide relevant expertise and proceed ethically. I can also cooperate with several experts to meet the client´s demands.
Regulation is a changeable area in which we need to know how to adapt and react quickly. Based on my working experience, listening, discussion and recognition were always crucial to get successful results.
I had the pleasure of working with Miluše for a year in Zentiva at the Dossier Management Department and, following that, for another two years in the Regulatory Affairs department in Arriello Group. During these years, I found at first a wonderful mentor in her and later a great and reliable colleague. In her work Miluše is diligent, responsible and always seeking the best possible solution. As a natural leader, Miluše always tries to see the bigger picture. She is one of the most organized people I have ever met and her enthusiasm for regulatory affairs is remarkable. Miluše never misses an opportunity to learn something new and, subsequently, uses it to make her work even more efficient. Working with Miluše was very enriching for me on both professional and personal level and, as I know I can a hundred per cent rely on her, I look forward for the time when our career paths meet again in the future.
Ing. Šárka Linhartová,
RA & Medical Affairs Associate
During our cooperation with Miluše, she was mainly responsible for leading of new registrations for DCP/MRP procedures and also core compilation of the dossier for RoW. She is a great communicator and highly motivated to do things better. She is a very good leader and coach as well. I appreciate her in-depth understanding of the task and proactive approach while compiling the dossier for variation countries worldwide. She always drives her projects quickly with a high level of accuracy, knowledge, systematicity and effectiveness. Don´t expect long “small talks” from Miluše …..she always goes straight to the point to keep the meeting effective :-).
Ing. Lucie Matušková
Senior Global Regulatory Affairs specialist