Regulatory affairs pharmacist - Midrand
JOB OVERVIEW: Ensuring thorough, seamless product registration process and dossier maintenance. Ensuring that the company complies with all regulations and maintain comapanys pharmacovigilance requirements. DUTIES AND RESPONSIBILITIES: • Provide, Lead, manage, and execute strategic direction as the regulatory affairs pharmacist • Ensure and supervise that regulatory documentation meets relevant regulatory requirements and specifications. • Provide input to the regulatory strategy in-line with business objectives • Detailed understanding of regulatory guidelines and technical requirements • Manage and implement safety updates where required • Manage Chemistry Manufacturing and Controls (CMC / P&A) updates and variations • To ensure approval and compliance of printed packaging material and promotional marketing material. • License renewals with service providers i.e. SAHPRA, South African Pharmacy Council (SAPC) • Writing and developing of SOP in line with Global SOP’s • Manage internal and external audits (i.e.Global & SAHPRA) • Responsible for updates of dossiers, PI/PIL to ensure compliance with current legislation • Manage of product complaints and deviations • Managing and maintaining regulatory documentation filing system. • Ensuring regulatory compliance and quality related records are available and retained. • Co-ordinate product recall or market withdrawal when necessary • Obtain and distribute updated information on domestic and international laws • Report ADR to Global Safety and SAHPRA • Follow-up of Adverse Drug Reactions (ADRs), • Pharmacovigilance training of local staff • Answering of requests from the Regulatory Authority with co-operation with Global Safety MINIMUM REQUIREMENTS: • Education: o B. Pharm (Bachelor of pharmacy) o Registration with the South African Pharmacy Council (SAPC) • Job Training and Experience: o Minimum 5 years’ experience in Regulatory Affairs – (must have human medicine experience and biologicals) o Experience in Product registration (NCE) o Maintenance of dossiers and updating thereof o Pharmacovigilance experience / knowledge of collecting and reporting o Knowledge of SAHPRA submission portals o Launch procedures for new products o Knowledgeable and experience regarding QA processes, APQRs, customer complaints etc. o In depth knowledge of Regulations, Acts and Guidelines for South Africa and East Africa pertaining to dossier submissions and life cycle management. o Knowledge of the Marketing Code • Systems knowledge o Microsoft office suite including Word, Excel, Power Point at an Intermediate level. o Familiar with ZAZIBONA processes o Competent and experienced in eCTD submissions.
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