CTD pharmaceutical experience

Azienda privata · Cairo, Egypt · Posted 2026-07-02

Role Description The CTD pharmaceutical experience role is a full-time, on-site position based in Badr City. The role involves preparing, reviewing, and maintaining Common Technical Document (CTD) dossiers for regulatory submissions, ensuring accuracy, completeness, and compliance with relevant guidelines. Daily tasks include coordinating with formulation, quality, and regulatory teams to collect data, organizing documentation for new product registrations and variations, and tracking submission timelines. The individual will support responses to regulatory authority queries, update CTD documentation in line with new requirements, and assist in internal audits and documentation reviews. The role also includes contributing to the optimization of documentation processes, maintaining clear records, and supporting continuous improvement initiatives within the regulatory affairs function.Qualifications Solid understanding of CTD structure and regulatory requirements for pharmaceutical products, including Module 2–5 contents.Experience preparing and reviewing regulatory dossiers for product registration, variations, and renewals.Knowledge of GMP, quality systems, and pharmaceutical development processes, preferably in manufacturing or regulatory environments.Strong attention to detail, documentation skills, and ability to organize large volumes of technical information.Effective communication and collaboration skills for working with cross-functional teams and external stakeholders.Proficiency with standard office and documentation tools (e.g., word processing, spreadsheets, document management systems).Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life science field; advanced qualifications in regulatory affairs are an advantage.Prior experience in regulatory affairs, CTD compilation, or dossier management within the pharmaceutical industry is highly beneficial.Ability to work on-site in Badr City, manage multiple deadlines, and adapt to evolving regulatory requirements.

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