DRA Specialist

Ahealth care company with global reach. A product pipeline filled tothe brim. A team committed to scientific advancement.Think what's possible.A global healthcare leader, Novartishas one of the most exciting product pipelines in the industrytoday. A pipeline of innovative medicines brought to life bydiverse, talented, performance driven people. All of which makes usthe most rewarding employer in our field.DRA SpecialistJob Description: Archive registration targets(licences) in a minimum possible time to meet brand launch targets,supported by full documentation, record of correspondence regardingthe products from all involved medical and state institutions andregistration officesManage proactively the businessimplication of any changes of Russian legislation as well changesof our products reported by HQManage switches to OTCManage compliance of theproducts available on the market with registration license(including managing renewals and variations) allowing uninterruptedbusiness continuity. Participate in artwork approval process,ensure full compliance of the pack components with registereddocuments Manage Adverse Event Reporting, maintaincompliance with Corporate and local regulatoryrequirements. Ability to effectively participate inpotential local production or BD&L/Licensing projects(approval, licensing, certification)Manager.Minimumrequirements:Education:University degree, Medical, Pharmaceutical orBiologicalExperience:2 years experience gained in international /westernleading company;Good knowledge of pharmaceutical regulations andlocal regulatory practices, natural team player,Russian and English enough to hold written and oralcommunication with headquarter.Strong communication skills and high ethicalstandards, able to demonstrate theconsiderable achievements in the professionalfield.