Regulatory Affairs Specialist

Follow up annual regulatory plan execution

Review regulatory documents and ensure they are up-to-date.

Submission and follow-up new and registration 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, Pharmacy.

3:6 years of regulatory affairs experience, especially in 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.