Summary

• Provides regulatory submissions of dossiers for new registration, variation and renewal to Health Authorities
• Post-registration activities
• Promo materials review

Reporting line: Regulatory Affairs Group Manager

Essential Duties & 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.

Position Requirements

• Intermediate English;
• 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 RA;
• Attentiveness to details;
• Ability to work in a multitasking environment with strict deadlines;
• Ability to find non-standard solutions