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| Title: | 🌟 VACANCY: Regulatory Affairs and Responsible Pharmacist – Johannesburg |
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| Max Salary: | 75000 | ||
| Decription: | Our client, a highly reputable and well-established company in the pharmaceutical industry, is seeking a mature, experienced, and detail-oriented Regulatory Affairs and Responsible Pharmacist to join their team in Johannesburg. ________________________________________ Key Duties & Responsibilities Company Compliance • Ensure full compliance with SAPC, SAHPRA, and DOH legislation. • Operate in line with the Medicines and Related Substances Control Act and Pharmacy Act. • Manage printed packaging and promotional material compliance. • Oversee Quality Management System including SOP implementation, updates, and audits. • Coordinate with local laboratories for Post Importation Testing. • Approve and release product batches for market in line with regulatory requirements. • Maintain and update the Site Master File, SOPs, and Quality Manual. • Prepare for and support SAPC/SAHPRA inspections. • Ensure adequate training and documentation of staff competency. • Review and approve batch manufacturing documentation prior to production. Product Registration • Compile, screen, and submit new registration applications to SAHPRA. • Handle registration-related queries and maintain partner communication. • Submit product variations and renewals as per SAHPRA requirements. • Stay updated with local legislative changes and ensure ongoing compliance. • Submit regulatory dossiers using Docubridge eCTD. Documentation & Quality Management • Manage the regulatory document control system. • Ensure retention and availability of regulatory and quality records. Pharmacovigilance • Monitor and manage all adverse drug reactions across the group. • Ensure timely receipt, review, and appropriate responses. Reporting • Provide weekly project updates to the CBDO and CEO. ________________________________________ Minimum Requirements • BPharm Degree • 5+ years\' experience in Regulatory Affairs • Previous experience as a Responsible Pharmacist • Proven experience in Quality Assurance ________________________________________ Behavioural & Technical Competencies • High integrity, ethical, and confidential • Accountability and ownership of compliance • Strong leadership and interpersonal skills • Excellent communication and planning ability • Exceptional attention to detail • Conscientious, cooperative, assertive, and deadline-driven ________________________________________ To Apply: Please email the following to cvs4belinda@therecruiters.co.za: • Updated CV in Word format • Copy of your ID • Qualifications • Reference letters or contactable referees • A recent profile picture ________________________________________ 📌 Only candidates who meet the minimum requirements will be contacted. If you have not heard from us within 2 weeks, please consider your application unsuccessful. Join a leader in the pharmaceutical sector and take your compliance and regulatory career to the next level! |
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| Location | Johannesburg | ||
| Consultant: | Belinda McIntosh | ||
| Email: | cvs4belinda@therecruiters.co.za | Share This Job | |