Senior Regulatory Affairs Portfolio Manager

About the role

Abbott is hiring a Senior Regulatory Affairs Portfolio Manager in Johannesburg, South Africa, within its Established Pharma division. The role covers the registration of new products and maintenance of existing registrations for the portfolio of products in the English Africa Cluster (EAC), while keeping the regulatory landscape under review and liaising with regulators, internal teams and external stakeholders.

Key responsibilities

• Register new products: guide regulatory strategy, work with the Regional Product Lead on submissions, prepare dossiers and appeals, and handle deficiency letters.
• Maintain existing registrations: submit technical updates, amendments and package insert changes, renewals and approved promotional material.
• Monitor legislation and regulatory authority requirements, attend regulatory meetings and liaise with NMRA technical representatives and health authorities.
• Liaise with Business Development, QA, Medical Information, Sales & Marketing, Operations and the regulatory team, and manage regulatory risks.
• Manage regulatory associates, consultants and team members, supervise RA associates and interns, and act as department head in meetings when required.
• Ensure compliance with Abbott's quality systems, maintain quality documents and SOPs, train staff, and uphold data integrity and good documentation practice.
• Report quality complaints, deviations, exceptions and significant events to quality within 24 hours, support investigations, CAPA actions, change controls, audit readiness and product recalls.

Required profile

• 2 to 3 years of regulatory affairs experience.
• Bachelor of Pharmacy or Pharmaceutical Science degree.
• Attention to detail and ability to work as a team player.
• Understanding of local guidelines.