Miluše HERYŠEROVÁ

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.  

MY SERVICES

MY VALUES

SKILLS