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

Key Responsibilities include but are not limited to:

• Strategic Leadership: Provide technical leadership on local and international regulatory strategies for biological medicines, aligned with guidelines from WHO and other National Regulatory Authorities (NRAs).
• Advisory Role: Advise on SAHPRA regulations, policies, and guidelines for biological medicines, including vaccines and biotherapeutics.
• Application Assessment: Evaluate quality (Chemistry, Manufacturing, and Control – CMC) aspects of registration applications for vaccines, biosimilars, and biotherapeutics to ensure compliance with relevant legislation and international standards.
• Quality Assurance: Act as a peer reviewer and mentor for quality assessments, ensuring thorough and accurate evaluation of biological submissions.
• Capacity Building: Lead training and mentoring initiatives to enhance technical expertise within SAHPRA.
• Global Collaboration: Liaise with industry stakeholders and international regulatory bodies to advance regulatory best practices.

Performance Expectation include but are not limited to:

• Demonstrate strong analytical, leadership, and problem-solving skills to address complex regulatory challenges.
• Develop and implement strategies to ensure SAHPRA's quality assessment of biological medicines adheres to the highest ethical and scientific standards.
• Consistently deliver high-quality, evidence-based quality assessments that meet deadlines and contribute to well-informed regulatory decisions.
• Develop and deliver training programs that effectively transfer knowledge and skills to colleagues, fostering a strong team of Biological product quality assessors within SAHPRA.
• Be an effective mentor and team player with excellent collaboration and communication skills.
• Maintain strong organizational skills and resilience in a fast-paced environment.
• Adhere to South African data protection laws and SAHPRA's specific data protection policies

Qualifications and Expertise

Essential:

• B. Pharm Degree with a Master’s in Pharmacology (NQF) Level 09) as evaluated by South African Qualifications Authority (SAQA), or a PhD in Biomedical Sciences or a related qualification (NQF Level 10)
• Registration with the professional bodies
• A minimum of 10 years of experience in compiling and/or reviewing quality aspects of biotherapeutic or vaccine Common Technical Document (CTD) dossiers.
• Strong knowledge of international guidelines and regulatory standards for biological medicines.

Preferred:

• Postgraduate qualifications in biotherapeutics/vaccine development, pharmaceutics, or the regulation of biological medicines.
• Experience in hybrid or remote collaborative work environments.