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.
