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 :-).
EXPERIENCE
2013-2017
Regulatory Specialist
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.
2017-2020
Regulatory Manager
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.
2020-now
Regulatory Consultant
INDEPENDENT CONSULTANT
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.