- Follow up annual regulatory plan execution
- Review regulatory documents and ensure they are up-to-date.
- Submission and follow-up new and reregistration process.
- Responsible for follow-up process at different EDA departments as variations, layouts, inserts, and any required updates
- Follow up all registration processes in EDA, including stability, bioequivalence, inserts, packs, variations, inspection appeals, importation, release, and analysis till receiving final licenses
- receiving approvals and appeal submission for different EDA departments
- submission and follow-up analytical dossiers to EDA
- ensure all documents are complied with company rules and national regulatory guidelines
- carefully review compiled files to ensure the content, quality, accuracy, and format of the submission
- CTD file preparation and submission
Bachelor's degree in pharmaceutical science.3-5 years of regulatory affairs experience, especially on human medicine registration.Awareness of all regulations and guidelines related to regulatory functions.Promptly respond to authorities requirements and promptness in deliverables.CTD experience; e-CTD is a plus.Details-oriented, multitasker, accountability.Effective Communication, Time Management.Good command of English language and excellent computer skills.