Junior Executive Regulatory Affairs

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

Role Summary

• Preparation of dossiers for submission by collecting, collating and evaluating scientific data that has been researched by colleagues; and by developing and writing clear arguments and explanations for new product registration.
• Preparing renewal and variation files by collecting, collating, and evaluating scientific data for submission as per the timeline.
• To assist supervisor to prepare response to inquiries received from regulatory agencies by seeking necessary information, data and reports.
• Coordination with internal/external stakeholders so as to ensure the availability of required documents/samples for the fulfillment of the dossier preparations and submissions to regulatory agency .
• To maintain the status of all projects and activities being handled and participated through the system(s)/software(s) implemented for the purpose.
• To undergo training and maintain their proper records.
• To work on specialist computer software(s) and resources like eCTD/NeeS (Lorenz docuBridge, Extedo), SAP, Regulatory Information Management.
• Assist in ensuring regulatory compliance via regulatory evaluation of Change Requests and full products’ life cycle management.
• Upload of product information on relevant portals like Brand Sync, SDI etc
  
  

Qualifications

• Saudi National is preferred.
• Bachelor of Pharmacy/Science, Or Master of Pharmacy/Science
• 1 to 3 years’ experience in regulatory affairs.
• Having regulatory and scientific knowledge for product registration, renewal of marketing authorizations, variations as per current regulations in Saudi Arabia, GCC and other regions/ countries.
• Excellent oral and written communication.
• Excellent interpersonal and collaboration skills.
• Proficient computer skills including MS Office Applications, eCTD