International Regulatory Affairs Specialist

Sanovel İlaç

• 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.