REGULATORY PHARMACIST NEEDED FOR CAPE TOWN IN SOUTH AFRICA

ABLE TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOWProduct registration Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required Compile and submit all required dossier amendments Identify and maintain updates on existing products based on MCC guidelines and allocated priorities Interact on a regular basis with overseas affiliates, third parties and contractors on dossier related activities Compile and submit all MCC recommendations within agreed and specified time limits Submit variations in neighbouring countries in line with South African dossier requirements Assists with dossier submission in neighbouring countries Manage and compile dossier conversions as per MCC guidelines Technical / Compliance activities Assist with annual product reviews Assist with technical queries internally and with the guidance of line management, externally Assist with pharmacovigilance activities as and when required Manage and monitor the Change Control Process effectively Packaging and marketing materials Review and assist with approval of printed packaging components and promotional material Assist with compilation, review and approval of advertising material Ensure all printed material (including web based), complies with the Marketing Code of Conduct and MCC requirements Document management Ensure the EDMS is current and up to date and in line with printed dossiers. General Perform any other duties as per changes in operational requirements of the department. Perform any other duties as requested PRE-REQUISITES B. Pharm registered with the SA Pharmacy Council Minimum of three years solid Regulatory experience within the Pharmaceutical Industry Able to perform all standard registration processes under specialist guidance TECHNICAL COMPETENCIES REQUIRED Experience of the pharmaceutical industry, preferably generics Computer literate and able to effectively use Excel and Word Able to perform all aspects of registration processes BEHAVIOURAL COMPETENCIES REQUIRED Professional and presentable Effective written and verbal communication skills Highly organized and good planning skills Self-discipline and effective administration skills Highly accurate and has good attention to detail Positive attitude Self-motivated Work well as part of a larger team