Collect and coordinate information and prepare regulatory CTD documentation for submission to regulatory agencies, authorities or to commercial partners.
Expertise proficiency with software tools and matrices for CTD submission.
Select and prepare CTD for products according to management instructions.
Coordinate with the R&D, Q.C, Q.A, Production, Supply chain and Marketing team members regarding the different registration issues and documents required for CTD preparation.
Ensure confidentiality in respect of CTD registration files contents.
Review carefully compiled CTD files to ensure that content, quality; accuracy and format of submission comply with applicable regulations of different markets.
Perform other related duties as assigned.
المهارات
BSc of pharmaceutical sciences
3-4 years of experience in CTD files preparation is a must
Excellent Computer skills
Very good command of the English language, read, written and spoken
Having good organizational and communication skills
NERHADOU is Ranked among the top 50 leading corporates for 6 consecutive years out of 1200 Pharmaceutical Corporates in Egypt in terms of Market Share of Pharmaceutical Products’ Domestic Sales (2019).
