Kıdemli Ruhsatlandırma Uzmanı İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Qualifications
- University degree from a reputable university in pharmacy, chemical engineering or other related life sciences
- Minimum 4 years of experience in local Regulatory Affairs
- Experience in preparation of registration dossiers in CTD format,Type I-Type II variations, analysis submissions
- Capable to respond flexibly to changing project priorities and work assignments
- Good knowledge of requirements to manage registration process until marketing authorization
- Follows new developments, has a result-oriented and analytical mindset, attaches importance to teamwork.
- Fluency in English
- Excellent MS Office knowledge,
- Good at time-management
- Collaboration and active communication
JOB DESCRIPTION
- Submits CTD, analysis, and variations dossiers.
- Follows the correspondence of the Ministry and ensuring that they are answered on time to achieve the targeted regulatory timelines.
- Follows the announcements, circulars and regulations published by MoH and ensuring that necessary actions are taken.
- Prepares of SPC-PIL submissions and follows updates
- Leads artwork coordination for the portfolio under responsibility
- Follows updates in published lists on MoH web-sites
- Provides communication with the required departments (R&D, BD, etc) and third parties.
- Researches on molecules/products for BE study requirements
