A leading South African pharmaceutical company is seeking a dedicated and experienced Regulatory Affairs Pharmacist to join their dynamic regulatory team. In this role, you will play a crucial part in ensuring full compliance with South African regulatory guidelines, overseeing file compilation, submissions, and maintaining life-cycle management for various pharmaceutical products.
Key Responsibilities
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Regulatory Submissions & Lifecycle Management: Compile, review, and submit high-quality registration dossiers to the South African Health Products Regulatory Authority (SAHPRA) for new market authorizations, variations, renewals, and maintenance.
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eCTD & Document Management: Utilize DocuBridge and relevant regulatory management systems to prepare, publish, and archive electronic dossier submissions in eCTD/e-submission format.
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Compliance & Monitoring: Keep abreast of evolving SAHPRA regulations, guidelines, and international standards, ensuring all corporate product lines remain fully compliant.
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Cross-Functional Collaboration: Partner with medical, quality assurance, marketing, and supply chain departments to provide regulatory guidance and facilitate smooth product launches and lifecycle strategies.
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Authority Interaction: Serve as a primary point of contact for SAHPRA communications, responding effectively to regulatory queries and requests for information.
Requirements & Qualifications
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Education: Bachelor of Pharmacy (BPharm) degree.
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Professional Registration: Active registration with the South African Pharmacy Council (SAPC) as a Pharmacist.
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Experience: Minimum of 5+ years’ hands-on experience in pharmaceutical Regulatory Affairs.
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Technical Expertise: Proven, in-depth experience working with SAHPRA guidelines/processes and expertise in using DocuBridge systems for electronic submissions.
Our client is offering a highly competitive salary for this role based on experience.
Contact Hire Resolve for your next career-changing move. Apply for this role today, contact Thomas Stacey at Hire Resolve or on LinkedIn. You can also visit the Hire Resolve website: [URL Removed] or email us your CV: [Email Address Removed].com
Desired Skills:
- Regulatory Affairs Pharmacist
- Regulatory Affairs Pharmacist
- Regulatory Affairs Pharmacist
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