Regulatory Affairs Pharmacist - East London Verfied

Salary Negotiable East London, Eastern Cape East London, Eastern Cape more than 14 days ago 29-07-2014 4:01:07 PM
26-08-2014 4:01:07 PM
An exciting opportunity for a registered Pharmacist is available within the Regulatory Affairs department. The successful incumbent will have relevant Regulatory Affairs experience and be registered with the Pharmacy Council. The candidate will preferably have completed the Medicines Registration course and must have strong knowledge of GMP and MCC standards!

Responsibilities:
Preparation of dossiers (Product File) for the Medicines Control Council (MCC)
Ensure deficiencies for amendments are compiled and requested and incorporated upfront for timeous submission.
Ensuring sufficient time for timeous submission ensuring sufficient time for approval prior to implementation.
Project participation as identified.
Artwork validation
Attend to MCC queries
Apply for Certificate of Pharmaceutical Product (CPP) and GMP
Create and maintain of Package Inserts (PI) and Patient Information Leaflet (PIL)
Create and maintain the database where required
Requisition of raw material, final product samples and their certificates of analysis for export market
Attend to change control when there are issues that affect Regulatory Affairs
Assist in compiling information for Tender Applications