SARAH SULTAN

• Managing all the registration activities of pharmaceuticals and medical devices for the Saudi market.
• Handling all inquiries and maintain up-to-date knowledge on regulations.
• Proceeding all the registration reviewing and publishing on Extedo program, E-SDR and Ghad system.
• Established strong rapport with external stakeholders such as contract manufacturers, and clients for efficient communication and compliance.

• Managed export operations, ensuring timely delivery and customer satisfaction.
• Provide all needed documentations for the customer to achieve compliance with different global authority.

• Worked in the Drug Stability Department:

- Review and evaluate pharmaceutical stability studies.

- Ensure that the submitted files comply with the ICH and EDA guidelines.

- Handling all the issuance of Importing approvals, custom release and final release inspection process.

- Register pharmaceutical raw materials for global companies.

- Coordinate with regulatory authorities to ensure compliance with local and international laws.

- Register and inspect medical devices in the field of IVF (In Vitro Fertilization).

- Manage importation, customs clearance and inspection processes.

• From October 2018 to Present at Human Drugs Registration Department - Specialized Scientific Committees:

- Revising scientific files for human drugs new active ingredients according to 296 & 425 decrees.

- Searching in medical scientific references of countries references e.g. FDA, Vidal, EMA, TGA and clinicaltrials.gov.

- Preparing reports for different specialized Committees.

• From November 2015 to September 2018 at Human Drugs Reception Department (Final approvals):

- Revising final hard files and license extension for human drugs products according to 296 & 370 decrees.

- Preparing data and files for Technical Committee.

- Revising leaflets, packaging, stability studies & bioequivalence approvals before releasing final licenses.

- Perform and discuss all kind of meetings with companies’ representatives & internal authorities.

• From July 2013 to October 2015 at Dietary & Food Supplements Registration Department:

- Revising scientific and legal documents of companies’ products.

- Preparing data and files for dietary and herbal medicine scientific committee.

- Releasing initial agreements for approved products.