| Date | 2025-01-22 |
|---|---|
| Job Title | Regulatory Affairs And Responsible Pharmacist |
| Employer | More Information |
| Salary | Annual salary |
| Category | Scientific Qa |
| Location |
Gauteng / Johannesburg |
Job Summary
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 companys 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 SOPs, 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
Regulatory Affairs And Responsible Pharmacist position available in Gauteng, Johannesburg. This job position was posted by . The job has been posted on 2025-01-22 in the Scientific Qa category
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