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Job Description
- 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.
Skills
- 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
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