In a few words about me ...

Experienced consultant with a demonstrated history of working in the pharmaceutical industry. Skilled in Regualtory Affairs Requirements, Pharma Law, Generics, Medical Devices, Submissions, Post-authorization Maintenace, e-CTD, Serialization, R&D, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP). Strong business development professional graduated from Warsaw University of Technology. Familiar with most therapeutic areas.

Last position - Regualtory Affairs Department Manager at Fresenius Kabi Polska.

As a member of not one project team, I supported company projects from the registration site. At the pre-registration stage, my task was to provide expert advice on items or issues which would affect Regulatory and R&D project teams, I was developing optimization of registration strategies for selected in-house or license -developed products. In the case of in-house products, I supported R&D teams in preparing the right product development strategy and proper documentation and collecting the data required to prepare the registration dossier. I have been developing registration documentation for API and finished products in CTD formats. I carried out audits of product registration dossier both in-house and at licensors sites (Cipla Ltd, Lupin Ltd, Camlin Ltd, Cadila Healthcare Ltd., Belupo, SMB Laboratories SA, Rafarm S.A, Medochemie Ltd), indicating bottlenecks that could generate additional questions during registration. For the needs of the BU, I carried out regulatory assessments, provided guidance in areas of expertise.

In my work in registration, I faced challenges related to proper planning of submissions of applications preceded by preparatory pre-registration activities and activities that could not be predicted or planned in advance and resulted only during the course of the processes. In the registration phase, I was responsible for coordinating and answering questions to the registration authorities (MA applications, renewals and variations).

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