REGULATORY PHARMACIST - Cape Town Verfied Gold Badge

Salary Negotiable Cape Town, Western Cape Cape Town, Western Cape more than 14 days ago 13-11-2015 12:54:15 PM
11-12-2015 12:54:15 PM
REGULATORY PHARMACIST – CAPE TOWN

A leading Generic company has a vacancy for a Regulatory Pharmacist based in Cape Town.

PURPOSE OF THE POSITION:
• Manage the registration process for allocated therapeutic categories for new and existing products, including liaison with the relevant Health Authorities and third parties
ABILITY TO UNDERTAKE ALL OF THE RESPONSIBILITIES BELOW:
Product 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.

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