Specialist: Biological Medicine (Vaccine) Clinical Assessor at South African Health Products Regulatory Authority

Key Responsibilities include but are not limited to: 

• Strategic Leadership: Provide technical leadership on clinical and non-clinical assessments for biological medicines, aligning with local and international regulatory strategies, WHO standards, and other National Regulatory Authorities (NRAs). 
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines, ensuring compliance with global standards for biological medicines, including vaccines and biotherapeutics. 
• Application Evaluation: Conduct detailed assessments of safety and efficacy aspects in applications for biological medicines (biotherapeutics, biosimilars, and vaccines) in compliance with the Medicines and Related Substances Act (Act No. 101 of 1965). 
• Peer Review and Mentorship: Provide critical and analytical feedback as a peer reviewer, ensuring thorough evaluation of clinical and non-clinical sections of biological submissions. Train and mentor SAHPRA staff to enhance technical capacity. 
• Global Collaboration: Represent SAHPRA in international regulatory forums, engage with industry stakeholders, and drive innovation in regulatory science. 

 Performance Expectation include but are not limited to: 

• Collaborate effectively with multidisciplinary teams and engage with industry stakeholders on regulatory matters. 
• Transfer skill to SAHPRA staff and stakeholders on Biological Medicine (Vaccine). 
• Maintain resilience, adaptability, and a commitment to excellence in regulatory science. 
• Champion innovation in regulatory science to improve the efficiency and effectiveness of clinical assessments for biological medicines. 
• Adhere to South African data protection laws and SAHPRA's specific data protection policies 

Application Criteria: 

Qualifications and Expertise 

Essential: 

• B. Pharm Degree or MBChB with a Master’s in Pharmacy (NQF) Level 09) as evaluated by South African Qualifications Authority (SAQA), 
• Registration with professional body 
• A minimum of 10 years of experience in evaluating safety and efficacy for biological medicines, including product information and patient information leaflets. 
• Proven knowledge of international guidelines and regulatory standards for clinical aspects of biological medicines. 

Preferred: 

• Postgraduate qualifications in virology, vaccinology, or pharmacology of biotherapeutics. 
• Expertise in clinical trials, biological dossiers, and regulatory compliance. 
• Experience in hybrid or remote collaboration models.