Regulatory Affairs Officer

Date:  22 Feb 2024
Location: 

Riyadh, SA

Company:  Baxter Company Ltd
Department:  Corporate Affairs
Sub Department:  Corporate Affairs - Regulatory and Registration
Number of Openings:  1

Role Purpose

This role is responsible for the coordination and preparation of documents and packages for regulatory submissions. The Regulatory Affairs officer is responsible for evaluating technical and scientific data and reports required for submission in support the company products.

Job Accountabilities & Activities

 

- Compiling and submitting in a timely manner, all regulatory documents on behalf of Baxter Company Limited in line with regulatory requirements. Respond to any regulatory queries within strictly provided deadlines. Maintain regulatory files in a format consistent with company and SFDA requirements. Manage all regulatory requirements relating to the specific portfolio of company products. 
- Reviewing and approving labeling and SOPs.
- Support Pharmacovigilance activities on behalf of the company and maintain effective communication with the SFDA throughout this process. 
- Manage the medical device registration process on behalf of the company with the SFDA. Provide a medical device problem and recall reporting system to the SFDA – Medical device department.

 

Education & Certifications

Bachelor's Degree or country equivalent in Pharmacy or related scientific discipline
 

Required Years of Experience

 

minimum of 4 years regulatory or equivalent experience within a pharmaceutical company or similar organization