Summary of Position
Regulatory :
Regulatory Responsibilities
Responsible for :
- preparation of good quality dossiers and submissions according to specified timelines, in designated countries, to ensure earliest registrations and approvals.
- preparation, review and approval of product labelling.
- review and approval of product promotional materials.
- management of local pharmacovigilance activities
Quality Responsibilities
Responsible for :
quality oversight of activities in a defined scope (manufacturing, warehousing and distribution.QC checks and release of locally manufactured products (Act 36 / 1947) and imported products (Act 36 / 1947 and Act 101 / 1965).quality documentation e.g., SOPs, Annual Product Reviews and Batch Manufacturing Documents.self-inspections and external auditsassisting QA Manager in complex and external audits as requiredRequirements
Must have Matric / Grade 12Pharm degreeRegistered with The South African Pharmacy CouncilMinimum 2 years Quality Assurance Management experienceMinimum 2 years’ experience as a Responsible PharmacistMinimum 2 years’ experience in compilation and submission of Act 101 (SAHPRA)and Act 36 (DALRRD) dossiersCTD dossier format submission experienceThorough understanding of GDP / GMP / GWPMS Word, Excel and PowerPoint – intermediate to advanced skills required.High accuracy and attention to detail skillsStrong work ethicThe following would enhance your position
GDP / GMP / GWP Training / CertificateAnimal Health industry experienceKnowledge of regulatory submissions in Botswana, Namibia, Zambia and ZimbabwePharmaceutical Production knowledge.Main Accountabilities
Regulatory :
Act as Deputy Responsible Pharmacist for the entity.Execute Regulatory StrategyAgency contactPreparation and submission of dossiersMaintenance &Lifecycle Management of product dossiersProject ManagementRegulatory due diligence on potential opportunitiesManagement of local Pharmacovigilance activitiesQuality : Responsible for :
QMS & DocumentationConduct training on quality activitiesAudits & inspections.#J-18808-Ljbffr