Bachelors degree in Chemistry, Chemical Engineering, Pharmacy, Molecular Biology and Genetics; master degree in relevant field will be preferred,
Minimum 3 years of International Regulatory Affairs experience in a pharmaceutical company,
Knowledge and understanding of global regulatory procedures,
Strong commitment to compatibility, scientific quality and integrity,
Having a high sense of empathy and being curious about everything new and unusual,
Managing relationships and responsibilities with collaboration, owning learning agility,
Exellent command of English (both written and spoken),
Very good knowledge of MS Office applications.
JOB DESCRIPTION
Conducting and following up the correspondence for registered products, making variations required, preparing renewal dossiers for Regular (EU-countries, US) and Non-Regular (CIS, MENA, Balkans, Africa, Asia-Pasific etc.) markets in English language,
Preparing registration dossiers in CTD format for own developed products, variations required (Type I/II) in English languages, sending samples for analysis, getting licence and sales authorization,
Ensuring coordination and collaboration with concerned departments and Representatives Offices (Intellectual Property, Medical, Factory, Partners, Consulting Companies and Representative Offices) and taking a decision in common,
Preparing, verifying and confirmation of all packaging materials from registration to exportation stages for all countries,
Preparing registration dossiers in CTD format in English for products to be registered in new markets and sending the dossiers to consulting firm; providing/preparing required information and documents,
Preparing and controling all documents for GMP application to the Authorities in foreign countries, following up the GMP inspection process until receiving GMP certificate of conformity,
Following up international regulations and guidelines concerning registration and participating international seminars and exhibitions.