Junior Executive Regulatory Affairs
2 weeks ago
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.
- Assisting the supervisor in preparing responses to inquiries received from regulatory agencies by seeking necessary information, data, and reports.
- Coordination with internal/external stakeholders to ensure the availability of required documents/samples for the fulfillment of the dossier preparations and submissions to regulatory agencies.
- Maintaining the status of all projects and activities being handled and participated through the system(s)/software(s) implemented for the purpose.
- Undergoing training and maintaining proper records.
- Working on specialist computer software(s) and resources like eCTD/NeeS (Lorenz docuBridge, Extedo), SAP, Regulatory Information Management.
- Assisting in ensuring regulatory compliance via regulatory evaluation of Change Requests and full products' life cycle management.
- Uploading 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.
- 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 skills.
- Excellent interpersonal and collaboration skills.
- Proficient computer skills including MS Office Applications and eCTD.
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