Regulatory Affairs Specialist
5 days ago
At Jamjoom Pharma, we are dedicated to delivering high-quality pharmaceutical products to the Middle East, Africa, and CIS regions. As a Junior Executive Regulatory Affairs specialist, you will play a key role in ensuring regulatory compliance for our innovative medical products.
Responsibilities- Preparation of dossiers for submission by collecting, collating, and evaluating scientific data from colleagues, and developing 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 supervisors in responding to inquiries received from regulatory agencies by seeking necessary information, data, and reports.
- Collaboration with internal/external stakeholders to ensure availability of required documents/samples for dossier preparations and submissions to regulatory agencies.
- Maintaining project status through implemented system(s)/software(s) and undertaking training with proper record-keeping.
- Utilizing specialist computer software(s) and resources like eCTD/NeeS (Lorenz docuBridge, Extedo), SAP, and Regulatory Information Management.
- Evaluating Change Requests and full products' life cycle management for regulatory compliance.
- Uploading product information on relevant portals like Brand Sync, SDI.
- Prioritizing Saudi Nationals.
- Bachelor of Pharmacy/Science or Master of Pharmacy/Science degree.
- 1-3 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.
- Strong interpersonal and collaboration skills.
- Proficiency in MS Office Applications and eCTD.
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