- In-depth knowledge of all regulatory processes and guidelines in Egypt, including specific processes for pricing, bioequivalence files, stability studies, and variations.
- Strong practical experience in CTD dossier preparation is a must.
- Understanding of international guidelines like ICH is advantageous.
A bachelor's degree in Pharmaceutical Science is a common requirement.Fluent in both written and spoken English and Arabic.Excellent communication, negotiation, time management, and organizational skills.Detail-oriented, a proactive problem-solver, with the ability to manage multiple projects and work effectively in cross-functional teams.Typically, 3-6 years of relevant experience in a regulatory affairs role within the pharmaceutical industry, with proven experience in local registration processes.