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Alberton
Ame Prinsloo

Ame Prinsloo

MBA | Pharmacist | Regulatory Strategist

Pharmaceutical / Bio-tech

Alberton, Ekurhuleni Metropolitan Municipality

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Services offered

I am a strategic Pharmacist and MBA graduate with over 21 years of experience driving regulatory affairs, clinical practice, and pharmaceutical business operations. My expertise spans the full regulatory lifecycle—from eCTD dossier compilation and SAHPRA submissions to GxP compliance, QMS implementation, and pharmacovigilance management. I have successfully launched and scaled pharmaceutical startups, optimized retail pharmacy operations, and delivered primary healthcare services to diverse patient populations. Currently serving as a RAWP Resident, I provide high-level regulatory consulting and business strategy, helping clients achieve compliance, market readiness, and sustainable growth. Passionate about knowledge-sharing and process optimization, I thrive on transforming complex regulations into clear, actionable strategies that empower healthcare organizations and improve patient outcomes.

Approximate rate: ZARR 300 per hour

Experience

I am a seasoned Pharmacist and MBA graduate with over two decades of expertise spanning regulatory affairs, clinical practice, and pharmaceutical business operations. My career highlights include leading regulatory submissions and eCTD dossier compilations, implementing Quality Management Systems, and managing pharmacovigilance activities for both startups and established companies. I have successfully guided pharmaceutical ventures from concept to market readiness, optimized retail pharmacy operations, and delivered primary healthcare services to diverse patient populations. Currently serving as a RAWP Resident, I provide strategic regulatory consulting and business development support, helping clients achieve compliance, operational efficiency, and sustainable growth. 

Education

I hold a Bachelor of Pharmacy (2002) and a Master of Business Administration (2008) from North-West University, where I was recognized as a Top Performer. To strengthen my regulatory expertise, I recently completed advanced certifications including the Pharmers Academy Regulatory Affairs Course (Premium Distinction, 2025), multiple RASCP Masterclasses in eCTD dossier compilation, and specialized training in Good Manufacturing Practices, Pharmacovigilance Systems, and DocuBridge software. I am also pursuing Primary Care Drug Therapy certification to expand my clinical scope, ensuring a strong foundation that bridges pharmacy practice, regulatory affairs, and business strategy.  
 

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