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Job Description
- Clearance of Registration samples from MOH supervising stock movements of finished products registration samples,reference standards,recipients and degradation products
- Package insert implementation for local package insert including translation and variations.
- Packaging materials updating and labeling to ensure design manufacturer’s requirements according to the rules.
- Compilation of registration and re-registration files including the official application forms and the follow up of the registration process to fulfill specific pending items.
- Handling toll manufacturing products including:
- Fast track preparation for the first batch to conduct Bioavailability studies.
- Preparation of AP’s and ingredient’s, packing ….. ect.
- Follow up steps for registration and re-registration of new products including pricing, stability, Bioequivalence, packaging …. Ect
- Follow up constantly with the manufactures.
- Regular visits to MOH for drug registration, pricing committee for pricing approval and technical committee for registration approvals.
- Dealing with NODCAR for analysis and conformity.
- Updating the registration status overview and liase with MOH for documents:CPP’S,declarations,TS’s,MS’s,stability data, legalized documents.
- Support local production for artwork preparation and variations.
- Provide Strategy, ideas, planning of regulatory progress:
- Ensure that launch plans are timely set up.
- Study circulars issued by MOH related to drug regulations.HPLC
- Coordinating the business with manufacturing partners, Quality control/quality assurance.
- Follow up of product complaints, quality defects recalls.
- Monthly production plan.
- Stocks of raw materials/excipients.
- New Purchase orders of active substance.
- Pricing, re-pricing follow up.
- Customs release Follow-up.
- Contracts Follow-up.
- Drug planning and policy center:
- Apply for an import license.
- Liaise with pricing committee for price approvals.
- Liaise with pricing committee for a price increase.
- Follow-up approval to proceed registration through the registration committee.
- Follow-up release of importation of registration samples-promotion samples and sales goods.
- Follow-up bulk importation(e.g.Mobic amps)
- MOH department of pharmaceutical affairs:
- Scientific office inspection/license… etc.
- National Organization for drug control and research:
- Conformity analysis for newly registered products.
- Release for newly launched products.
- Release of promotional samples.
- Follow-up supply of excipients, degradation products, columns for HPLC.
Job Requirements
- Past experience in registration for at least 1 year.
- Past experience of 1 year dealing with manufacturer’s coordination.
- Pharmacy graduate.
- Perfect English language.
- Computer skills MS office (word, excel, PowerPoint).
