Katia Nikolaou

My name is Aikaterini (Katia) Nikolaou, I am a Chemist, I have an M. Sc. in Organic Chemistry and a Ph. D in Chemistry. For several years I have been performing synthesis of novel organic compounds and in vitro experiments, so as to study their activity against enzymes that are involved in various diseases, mainly inflammatory ones, including cancer. During my postdoctoral research, I also conducted in vivo experiments. Actually, one of the inhibitors I have synthesized exhibits in vivo efficacy in a pulmonary fibrosis model (J. Med. Chem. 2018, 61, 3697-3711).

The last four years I work within the pharmaceutical industry (R&D department), starting from being an R&D analyst, then an API and Chemical Synthesis Expert, a CMC Expert and finally the Head of CMC/R&D leading the preparation and update of documentation for initial submissions/ variations/ extensions/ renewals in line with ICH, EMA and FDA guidelines and regulations, making strategy for responses to deficiency letters raised by EU and non-EU authorities, reviewing quality documents and coordinating, compiling and reviewing CMC quality data package for appropriate and complete documentation in compliance with regulations, guideline and policies.

I am a very responsible person, I have excellent verbal and written communication skills in English (Proficiency) (I also speak French and Japanese), I have an ECDL Core Certificate (computer literacy) and I am very enthusiastic with everything new.

I’m excited about employment opportunities within your company and hope to explore contributions I can make.

The last four years I work within the pharmaceutical company DEMO SA Pharmaceuticals (R&D department), starting from being an R&D analyst (May 2019-Aug 2019), then an API and Chemical Synthesis Expert (Sep 2019-Mar 2021), a CMC Expert (Apr 2021-Oct 2022) and finally the Head of CMC/R&D (Nov 2022-Today) leading the preparation and update of documentation for initial submissions/ variations/ extensions/ renewals in line with ICH, EMA and FDA guidelines and regulations, making strategy for responses to deficiency letters raised by EU and non-EU authorities, reviewing quality documents and coordinating, compiling and reviewing CMC quality data package for appropriate and complete documentation in compliance with regulations, guideline and policies.

I am a Chemist, I have an M. Sc. in Organic Chemistry and a Ph. D in Chemistry. I obtained all the above degrees in the National and Kapodistrian University of Athens, Greece. I also performed Post-Doctoral research (Oct 2016-Apr 2019).

I have excellent verbal and written communication skills in English (Proficiency certificate).

I also speak French (Delf 1) and Japanese (N5).

I have an ECDL Core Certificate (computer literacy).