J&J Family of Companies Regulatory Affairs Specialist in Москва, Russia

Janssen is currently looking for a Regulatory Affairs Specialist to join its Regulatory Affairs Team.

Main responsibilities:

  • Coordination, creation, reviewing, proofreading and approval of packaging materials and inserts in accordance with approved documents in Russia.

  • Preparation of (variation) dossier for submission according to MoH requirements

  • Execution and follow-up of all stages of (variation) approval process, starting from dossier submission up to (variation) approval, including package materials and Package Insert leaflet preparation, technical document preparation, pharmaceutical expertise issues, communication with HA, etc.

  • Communication with regulatory contacts in HQ and GRA for obtaining necessary documents and materials, negotiations in case of any specific cases/issues.

  • Ensure that product information and packaging materials are updated with the most recent variations/CCDS and local requirements at any time.

  • Communication with local HA, Regulatory Bodies and local pharmaceutical associations (AIPM, etc)

  • Maintenance of the regulatory data bases and files

Требования к кандидату

  • Higher education

  • 0-3 years of professional experience in a foreign pharmaceutical company

  • In-depth knowledge of regulations/legislation

  • Strong in data gathering & interpretation

  • Analytical, detail driven

  • Good communicator

  • Constructive team player

  • English – Upper-Intermediate

  • PC experience: MS Word – working level, MS Excel - basic

Основное местоположение

Россия-Москва-Москва

Организация

J&J LLC Russia (8431)

Вакансия

Нормативно-правовое регулирование

Requisition ID

000019U8