Company Info
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Primary Purpose of the position:
• Provides regulatory submissions of dossiers for new registration, variation and renewal to Health Authorities
• Post-registration activities
• Promo materials review
Responsibilities:
• Registration dossiers preparation for the submissions, variations and renewals and their submission to the competent national regulatory authorities;
• Taking the necessary measures to ensure compliance with the planned timing of new product registration, renewal and variations traded products;
• Realization of business correspondence with the Health Authorities pertaining to the regulation of drug products;
• Cooperation with manufacturing sites (business correspondence, regulatory strategy, timely informing etc.);
• Cooperation with related Department of Teva company;
• Monitoring changes in the regulatory framework of regulatory processes (laws, regulations of the Government of the Russian Federation, orders, letters, etc.);
• Review of the promotional materials.
Requirements:
• Higher medical or pharmaceutical education
• Knowledge of:
Current RU legislation, coming EEU legislation
RA procedures
Fundamentals of GMP, GLP and GCP.
• At least 2 years’ experience in Regulatory affairs
• Attentiveness to details
• Ability to work in a multitasking environment with strict deadlines
• Ability to find non-standard solutions
• English – intermediate
