Job Summary
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
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.
eCTD & Document Management: Utilize DocuBridge and relevant regulatory management systems to prepare, publish, and archive electronic dossier submissions in eCTD/e-submission format.
Compliance & Monitoring: Keep abreast of evolving SAHPRA regulations, guidelines, and international standards, ensuring all corporate product lines remain fully compliant.
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.
Authority Interaction: Serve as a primary point of contact for SAHPRA communications, responding effectively to regulatory queries and requests for information.
Requirements & Qualifications
Education: Bachelor of Pharmacy (BPharm) degree.
Professional Registration: Active registration with the South African Pharmacy Council (SAPC) as a Pharmacist.
Experience: Minimum of 5+ years’ hands-on experience in pharmaceutical Regulatory Affairs.
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: hireresolve.us or email us your CV: Manufacturing@hireresolve.za.com
About
Specialists in Civil, Structural, Mechanical Engineering, Information Technology, Mining, Manufacturing and Finance Careers! Hire Resolve is one of the larger and more agile South African recruitment companies that focus on placing professionals and skilled people in permanent employment and contract employment. We prefer and focus on working with top quality professionals and candidates in South Africa and Africa. Hire Resolve has successfully placed Engineering, Mining, IT, Manufacturing and Finance professionals with top firms across the Western Cape, Eastern Cape, KwaZulu Natal, Gauteng and in Africa. Hire Resolve has assisted candidates to find jobs at over 100 JSE listed companies of which many are global companies with offices and operations in South Africa and Africa. It is for this reason that we are well respected in the industries we operate in and in the recruitment industry.
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