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.
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
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
Constructive team player
English – Upper-Intermediate
PC experience: MS Word – working level, MS Excel - basic
J&J LLC Russia (8431)