Vaccine Registration Manager: Africa

• Bachelor’s degree in Pharmacy (B. Pharm), or suitable Bachelor of Science degree
• 5 years of experience in the vaccine – biotech industry
• 3 years of experience at management
• Hands-on experience in quality and regulatory compliance within a cGMP (current Good Manufacturing Practice) facility.
• Proficiency in business and operational planning, program, and project management.
• Experience in developing departmental budgets
• Background in regulatory compliance, with familiarity with regulatory bodies such as SAHPRA, ZAZIBONA (West and/or East Africa Community), and WHO.
• Experience in commercialization, auditing, and establishing contracts with 3rd parties.
• Demonstrated experience in a regulatory role within an African regulatory environment, particularly with product licensing in a manufacturing context.
• Strong networks with relevant regulatory authorities to ensure efficient regulatory processes.
• Lead efforts to achieve the site’s strategic objectives while managing risks related to workflow, ethics, quality, finances, and regulatory compliance.
• Identify and drive key opportunities to enhance or expand operations across departments.
• Manage or contribute to various site-wide or departmental projects.
• Monitor and report on critical business metrics and performance indicators to support short-, medium-, and long-term goals.
• Proactively mitigate risks in collaboration with the site management team and develop effective solutions.
• Ensure accurate budgeting, costing, and expense management for overlapping site activities.
• Oversee the planning, execution, and finalization of new implementations, ensuring projects are completed on time and within budget.
• Develop and implement regulatory strategies for new product applications and lifecycle management in different African markets.
• Prepare and submit regulatory applications, reports, and correspondence to relevant National Regulatory Authorities (NRAs).
• Respond to inquiries from regulatory agencies regarding product information and compliance issues.
• Ensure timely payment of regulatory compliance fees to NRAs.
• Formulate and enforce regulatory policies and procedures to maintain or improve compliance.
• Provide regulatory guidance to various departments and project teams on product design, development, evaluation, and marketing.
• Communicate regulatory information clearly to stakeholders, ensuring correct interpretation.
• Monitor emerging industry regulations to assess potential impacts on company processes.
• Represent the company in dealings with domestic and international regulatory agencies and African NGOs on major policy matters.
• Maintain up-to-date knowledge of relevant regulations, including proposed and final rules.
• Coordinate regulatory audits and inspections of third-party manufacturers within Africa.
• Provide regulatory input on change control, deviations, technical agreements, and advertising.
• Participate in inspections, investigations, risk management, and quality reviews.
• Work closely with local regulatory consultants to manage dossier submissions.
• Ensure the registration and compliance of products with regulations across various regions.
• Deliver regulatory assessments and advice as part of overall business planning and strategies.
• Regularly communicate changes in regulations affecting registered products to the company.
• Keep current on regulatory requirements and developments across different countries.
• Compile necessary documents for submissions, license renewals, and annual registrations.
• Collaborate with Regulatory Affairs pharmacists to maintain product registration dossiers.
• Ensure the quality and organization of all regulatory documents align with local/regional requirements.
• Maintain a database of regulatory requirements per country.
• Engage regularly with the Regulatory Affairs HOD to discuss regulatory issues and updates.

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