Skills Required المهارات المطلوبة
Quality
Pharmaceutical
Regulatory Compliance (EDA
NFSA
NRC)
Documentation & Data Management
Attention to Detail & Data Accuracy
Regulatory Documentation & Submission
Raw Materials Release & Sampling
CADC Submission & Follow-up
COA (Certificates of Analysis) Preparation
SAP (especially data handling / SAP QM)
Compliance
Finance
Pharmaceutical
Pharmacy
QC
Quality Assurance
Quality Control
Regulatory Affairs
Job Description الوصف الوظيفي
The job holder will manage and execute regulatory compliance activities for raw materials and finished products, including data preparation, documentation, submissions, and follow-up with regulatory authorities (EDA, NFSA, CADC, NORCB). Acts as primary owner for Raw Materials, COAs, and CRM activities while supporting finished product operations based on workload distribution. Position will be based in our site in Al Obour City and will report to Site Quality Assurance Manager.
Your Responsibilities:
Full ownership of EDA release, sampling, NFSA (imported & local) for raw material tasks including data preparation, document verification, submission, and SAP release.
Raw Materials CADC Management: Prepare and upload CADC files, follow up on analysis results, and manage retained and expired samples.
COAs Creation: Create Certificates of Analysis for raw materials and finished products
including first batches, random samples, new suppliers, biological and stability products.
CRM Management: Handle all CRM activities including accreditation, extensions, whitelist,
and coordination with QC
and CADC
Finished Products Support: Support sampling, CADC submissions, and regulatory
documentation for finished products
Archiving: Maintain proper archiving of all reports and compliance documents.
Financial Tracking: Monitor EDA & NFSA & NRC & EDA Ref Lab fees and support budget calculations