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Regulatory Affairs Officer Moscow ??? ???? ??????? Moscow

Regulatory Affairs Officer Moscow

2020-11-18 04:43:25
Regulatory Affairs Officer Moscow
(Maternity leave vacancy) Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 42,600 people in 79 countries and markets its products in more than 170 countries. Are you ready to make the next step in your professional development in a global expanding company? Join Novo Nordisk region AAMEO BANEC and get a life-changing career! Region AAMEO (Africa, Asia, Middle East, and Oceania) is one of the main drivers of Novo Nordisk’s growth today. Russia is a part of BANEC (Business Area of Near East and Commonwealth of Independent States) , - a vast region that includes 20+ countries. About the department Regulatory Affairs (RA) is an area within Clinical & Medical & Regulatory, responsible for... registration of Novo Nordisk products and devices in Russia. You will join a team of highly skilled Regulatory Affairs managers and specialists. You will be located at Moscow office facility. The position In your role as RA Officer you will carry out and maintain the process of new registration, submission of variations and renewals for medicinal products and medical devices under national and EAEU procedure. You will be an essential member of the regulatory team and have a significant role in obtaining HA approval related tasks in a proactive and independent manner. You will ensure the registration of new products and implementation of variations into the registration dossier of registered products in Russia; Prepare texts for leaflets of medicinal products and for packaging materials; Prepare submission dossier for NDAs/renewals/variations of medicinal products and medical devices, including: order necessary documents, registration samples, standards, columns and other materials at HQ, ensure the translation of the necessary documents and verify their correctness, prepare a package of documents for obtaining import permission. Also, you will monitor the changes in Russian national and EAEU legislations related to the circulation of medicinal products and medical devices. Qualifications You hold a University degree normally pharmaceutical education or life sciences Experience in an international pharmaceutical company for at least four years English verbal and written skills on upper-intermediate level Experienced user of Microsoft Office Package (Outlook, Word, Excel, PowerPoint) Knowledge of legislation related to the circulation of medicinal products and medical devices Knowledge of medical terminology Working at Novo Nordisk At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development
Moscow Russia
Regulatory Affairs Officer Moscow ??? ???? ??????? Moscow
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