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Job Description
Regulatory Affairs Specialist is required for a Multinational company located in 5th Settlement,
- Manage, follow-up and facilitate all registration related activities including NDA, variation and renewals with the health authority
- Complete all query demanded by government agencies to complete the registration of the products
- Request the required documents for the registration from the corporate and formation of the country specific registration dossier.
- Preparation of documents on KIPDIPS and preparation of eCTD dossiers.
- Ensure the timely renewal of all certificates eg. Registration certificate, CPPs, GMPs…etc
- Follow-up on the new country regulations & guidelines.
- Development of the product labels according to the country specific guidelines
- Maintenance of Kabi RegTrack company database to be always up to date
- Tender support (providing needed documents and applications for tenders if any)
Job Requirements
- Experience 1-5 years (mainly in the Pharmaceutical products field)
- Experience in eCTD file preparation and publishing for export companies
- Good command of English language and computer skills (word, excel, PowerPoint)
- Education: Scientific bachelor degree (Pharmacy graduates only)
- Ability to manage multiple projects and meet the deadlines.
