Christine Labib

1. Write clear user-friendly products labels and patient information leaflets content while ensuring label claims for compliance with SFDA regulations and maintaining commercially attractive labeling.
2.Respond to regulatory authority artworks modifications requests.
3. Submitting product registration applications through SFDA electronic systems.
4. Collection of different types of regulatory submissions example (CTD ,eCTD,medical device,cosmetics, food supplements) for submission to regulatory authority .
5. Proactively communicate with SFDA through online meetings/ SFDA letters for discussing registration difficulties.
6.Managing team of regulatory affairs Juniors.

1.Evaluation of manufacturer (certificates, regulatory
capabilities, samples)
2. Products evaluation (Evaluation form/Sample Evaluation
form)
3. Finalizing deal including negotiating price and other terms.
4. Finalize contract together with legal department and
other relevant involved departments.
5. Following up regulatory process with regulatory team.
6. Following with commercial team, initial order and forecast
plan.
7. Connecting logistics team to prepare for shipment.