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| Title: | Regulatory Affairs and Responsible Pharmacist |
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| Max Salary: | 840000 | ||
| Decription: | 1 Company Compliance: • To be responsible for overall company compliance to SAPC/SAHPRA/DOH legislation. • To ensure that the applicant operates in accordance with the provision of the Medicines and Related Substances Control Act, the Pharmacy Act and other applicable national legislation. • To ensure compliance of all printed packaging material and promotional material. • Responsible for the company’s Quality Management System; SOP implementation, update and compliance. • Coordinating with approved local laboratories for Post Importation Testing of all product shipments. • Responsible for batch release for all products • To ensure products released onto the market comply with approved registration dossier and quality control parameters. • To ensure that the company is legally licensed by SAPC, DOH and SAHPRA. • To ensure company operates in accordance with the provision of SAHPRA Section 22 C license issued. • To ensure the company SOP’s, Quality Manual and Site Master File are kept updated. • To ensure processes and systems are in place for SAHPRA/SAPC inspection purposes. • To ensure that personnel are adequately trained, and training records are available for inspection. • To ensure batch manufacturing and master documentation review and approval prior to production taking place. 2 Product Registration: • Responsible for screening, compilation and submission of new registration applications to SAHPRA. • Continuous engagement with company partners during and after product registration. • Response for resolution of pre-registration evaluation queries from SAHPRA. • Responsible for variation submissions to SAHPRA. • Responsible for renewal submissions to SAHPRA. • Ensure on-going regulatory compliance of the existing product portfolio. • Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department. • Ensuring that the company is aware of significant local regulatory issues which can impact the business. • Submission of dossiers/variations via Docubridge eCTD management software. 3 Documentation management: • Managing and maintaining regulatory documentation management system. • Ensuring regulatory compliance and quality related records are available and retained. 4 Pharmacovigilance: • Responsible for Pharmacovigilance monitoring within the group. • This involves receipt, review and response to all adverse drug reactions. 5 Other: • Providing weekly status reports to CBDO/CEO on the status of projects currently worked on. Minimum Requirements: Behaviourial Qualities: • Takes accountability for overall company compliance • Integrity, bound to principles, confidentiality and ethics. • Strong leadership skills. • Good communication skills. • Good organisational skills. • Good planning skills. • Good follow-up skills • Attention to detail • Assertive. • Conscientious. • Patient. • Co-operative. • Deadline Driven Desirable skills and experience: • B Pharm degree • 5 years’ experience in Regulatory Affairs • Experience in being a Responsible Pharmacist • Experience in Quality Assurance |
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| General Requirements: | Minimum Requirements: Behaviourial Qualities: • Takes accountability for overall company compliance • Integrity, bound to principles, confidentiality and ethics. • Strong leadership skills. • Good communication skills. • Good organisational skills. • Good planning skills. • Good follow-up skills • Attention to detail • Assertive. • Conscientious. • Patient. • Co-operative. • Deadline Driven Desirable skills and experience: • B Pharm degree • 5 years’ experience in Regulatory Affairs • Experience in being a Responsible Pharmacist • Experience in Quality Assurance |
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| Location | Johannesburg | ||
| Consultant: | Renee de Klerk | ||
| Email: | cvs4renee@therecruiters.co.za | Share This Job | |