CTD Specialist At UTOPIA Pharmaceutical Industry

UTOPIA is seeking qualified
CTD Specialist

🔶Job Purpose

Preparing product dossiers (CTD, eCTD, Regular files)
🔶Responsibilities and Duties:
-Preparing the CTD / e-CTD files for all Utopia’s products.
-Gathering, evaluating, and collating all required studies from the concerned department.
-Revision the DMF for all API’s suppliers and communicate with the supply chain to get the supplier response on the comments
🔶Knowledge
Technical
•Professional knowledge of pharmaceutical industry principles, methods, and applications.
•Knowledge of related EDA& international regulations (ex.: ICH, WHO, EMEA, GCC,…).
•Knowledge of analytical and instrumental methods including HPLC, GC, etc. ….
•Knowledge of Windows-based software programs

🔶Experience

•1--3 years experience in the pharmaceutical industry preferred in the same position
🔶Education
•Bachelor's Degree in Pharmacy or Science
🔶Skills & Requirements
Strong communication, negotiation skills & networking.
Very Good Computer skills
Ability to understand and implement instructions.
Good interpersonal skills.
🔶Location:
10th of Ramadan City, Egypt.
🔶 If you are interested, please send your updated CV and write CTD Specialist in subject to
yehia.elmasry@utopiapharma.com

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