Regulatory Pharmacist
A leading international Pharmaceutical Company is currently urgently looking for a Regulatory Pharmacist to be based at their South African Head Office in Pretoria

Salary: R30 – R35 000 per month

Key performance areas

Regulatory Affairs
• To compile and submit registration dossiers in accordance with the specific requirements of MCC
• Dossier Maintenance: Submission of post registration variations in line with regulatory requirements.
• Submission of updated product Package insert or labelling updates in line with regulatory requirements.
• To align regulatory product registration submission strategy to commercial product strategy
• Review of promotional materials to ensure adherence to country specific requirements

Pharmacovigilance
• Act as a Pharmacovigilance contact for Regulatory Authority (MCC) and ensure timely response to regulatory authority queries and request information
• Coordinate with Global PV cell and ensure timely submission of ADRs to the respective regulatory authorities
• Report processed ADRs to the local Regulatory Authority (MCC) as applicable, in accordance with local regulations and maintains a submission log.
• To handle (liaise with customers, patients and doctors where required) all of South African organiation
• PVG complaints and PQCs
• PV Training of all employee having customer interface

QA/QC function
• Ensuring quality check for each product batch imported in SA through assigned labs and release of stocks
• Oversees local quality assurance and quality control concerning all the company’s products
• Ensure maintenance and compliance of existing products in accordance with the Regulatory Health
• Authorities requirements

Education, Training and Experience
• B. Pharm degree; registered with SAPC
• 4 - 5 years working experience in Regulatory Affairs
• Extensive experience of the regulatory function in the pharmaceutical industry
• Extensive knowledge of generic pharmaceutical market