-Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;-Providing information on procedures in force and applicable legislation;-Managing national registration procedures to obtain Marketing authorizations in EU and non-EU countries; - Communication and close collaboration with internal and external parties to obtain required supporting documents for compilation of product CMC relevant documentation in line… Show more -Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;-Providing information on procedures in force and applicable legislation;-Managing national registration procedures to obtain Marketing authorizations in EU and non-EU countries; - Communication and close collaboration with internal and external parties to obtain required supporting documents for compilation of product CMC relevant documentation in line with ICH and EMA guidelines intended for post-approval submissions of Modules 2-3 and post submission phase of national procedures.- Responsible for Lifecycle Management: Maintenance of Marketing Authorizations:o by submission of appropriate variations for post-approval changes in European and Non-EU countries.o by submission of renewals in EU and Non-EU countries.- Maintain the GAP analysis of each project.-Monitoring of Registration procedures/answering queries of the competent Authorities;-(Be) involved in the preparation and review of regulatory submissions in order to support marketing authorization activities for company or external clients;-studying scientific and legal documents;-ensuring that quality standards are met and submissions meet strict deadlines;- (Be) involved in the review of product labeling and/or update of SmPC and Leaflets information.- Continuous follow-up of ongoing assigned projects, as well as update of the regulatory affairs' databases. Show less

- Keeping up-to-date with changes in regulatory guidelines ensuring products meet legislative requirements.- Communication with clients for the assigned projects.- Responsible for preparing documents necessary for the application, evaluation and approval by the competent Authorities.- Assessment of change controls on products’ quality dossier part in compliance with EU variation guidelines.- Communication and close collaboration with internal and external parties to… Show more - Keeping up-to-date with changes in regulatory guidelines ensuring products meet legislative requirements.- Communication with clients for the assigned projects.- Responsible for preparing documents necessary for the application, evaluation and approval by the competent Authorities.- Assessment of change controls on products’ quality dossier part in compliance with EU variation guidelines.- Communication and close collaboration with internal and external parties to obtain required supporting documents for compilation of product CMC relevant documentation in line with ICH and EMA guidelines intended for post-approval submissions of Modules 2-3 and post submission phase of national procedures.- Responsible for Lifecycle Management: Maintenance of Marketing Authorizations:o by submission of appropriate variations for post-approval changes in European and Non-EU countries.o by submission of renewals in Non-EU countries.- Monitoring of Registration procedures/answering queries of the competent Authorities.- Support during dossier assessment by competent authorities following strict timelines.- Continuous follow-up of ongoing assigned projects, as well as update of the regulatory affairs' database. Show less

- (Be) responsible for the review of existing dossiers (Modules 2-5) and proceed tocorrection/addition actions in order to be presented in updated CTD format; - Compilation of the pharmaceutical product dossier of new developments, as well as support, maintenance and upgrade of dossiers of completed developments.- Communication and close collaboration with internal (e.g. laboratory and manufacturing site of the company) and external parties to obtain required supporting documents… Show more - (Be) responsible for the review of existing dossiers (Modules 2-5) and proceed tocorrection/addition actions in order to be presented in updated CTD format; - Compilation of the pharmaceutical product dossier of new developments, as well as support, maintenance and upgrade of dossiers of completed developments.- Communication and close collaboration with internal (e.g. laboratory and manufacturing site of the company) and external parties to obtain required supporting documents data for compilation of the CTD dossier, supplements/variations, maintaining timelines of projects.- Support the transfer of the procedures to production.- (Be) involved in the compilation and monitoring of the progress of scientific responses todeficiencies raised by clients and/or Regulatory Authorities.- Support during dossier assessment by competent authorities following strict timelines.- Keep updated on regulations and guidelines published by competent authorities.- Keep record of updated versions of products’ dossiers. Show less

During that internship, I conducted research with respect to the expansion and purification of recombinant adenoviruses expressing beneficial forms of apolipoprotein E for experimental gene therapy approaches. Moreover, I had the privilege of practicing in some experimental techniques and methods such as Elisa, Western Blot, SDS- Page Electrophoresis and to develop further skills in the experimental design. As part of my work, I also validated the expression of the therapeutic genes by in vitro… Show more During that internship, I conducted research with respect to the expansion and purification of recombinant adenoviruses expressing beneficial forms of apolipoprotein E for experimental gene therapy approaches. Moreover, I had the privilege of practicing in some experimental techniques and methods such as Elisa, Western Blot, SDS- Page Electrophoresis and to develop further skills in the experimental design. As part of my work, I also validated the expression of the therapeutic genes by in vitro cell culture experiments and in vivo gene transfer to experimental mice. Generally, I learnt how to plan, conduct and evaluate experiments in compliance with health and safety regulations and research and interpret scientific literature. I had also the privilege to interact with professors, assistants and other members of staff on regular basis. This experience gave me not only the opportunity to have an insight into a laboratory but also improved my interpersonal communication skills and my ability to work together and cooperate effectively with other people. Show less