Менеджер по регистрации ЛС

по договоренности
Москва
Опыт от 3 до 6 лет

Company:

Our client, a biotechnology company engaged in the development, production and implementation of innovative medicines, opens a set for a vacancy RA Manager

Job Responsibilities:

  • Responsible for all RA deliverable linked to the registration and certification of the products in Russia, collecting the registration dossier for CIS region, maintenance of registrations in Russia and other countries of the CIS region
  • Prepare responses to regulatory agencies' questions and other correspondence
  • Organize and maintain reporting schedules for new product application and investigational new product applications
  • Supporting development and execution of regulatory strategies for assigned projects for Russia. This will include the creation of submission dossier compilation of documentation and managing of timelines
  • Monitoring drug legislation in Russia and identifying and conducting a review of regulatory requirements and changes in areas
  • Management of a subordinate team (from 1 to 2 RA Specialists)
    • Work Environment:

    • Salary – negotiable
    • Social package (supplementary health insurance, life insurance, mobile payment)
    • Work in American multinational biopharmaceutical company
    • Training and career opportunities
    • Office - in the center of Moscow within walking distance from the metro
      • Requirements:

      • Education: Pharmacy, chemistry, biology, medicine. PhD in pharmaceutical or chemistry is desirable
      • Experience: from 5 years in Regulatory Affairs with multinational company as a RA Manager and from 2 years as a RA Supervisor
      • Working knowledge of the current regulatory, political and legal environment
      • Upper-intermediate English (oral and written)
      • Able to build trust and high credibility with main stakeholders
      • Team-oriented
        • Тип занятости:

          Полная занятость, полный рабочий день, у работодателя

          Подпишитесь на подходящие вакансии