Global Regulatory Affairs Portfolio Lead

Neptune; South Africa; On-site; ZAR 900,000 - 1,500,000; Full time

Job summary

Abbott is seeking a Senior Regulatory Affairs Portfolio Manager in South Africa to lead regulatory strategy and compliance for product portfolios. You will ensure submissions align with global standards, manage NMRA registrations, and drive timely product approvals with cross-functional partners.

You will guide regulatory intelligence, oversee quality systems, and mentor RA staff while liaising with internal departments to support business objectives and product launches.

Qualifications

• 2-3 years RA experience.
• Bachelor of Pharmacy or Pharmaceutical Science.
• Strong understanding of local regulatory guidelines.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Registration of new products and preparation of registration packages for NMRA submissions.
• Maintain existing registrations and prepare technical updates and package insert amendments.
• Monitor regulatory changes and cascade them to local and global teams.
• Liaise with Business Development, QA, Medical/IPV, Sales/Marketing and Operations on regulatory needs and product launches.
• Maintain QA documents, SOPs and training for regulatory processes.
• Lead and mentor RA team members and lead cross-functional regulatory activities.
• Engage with external stakeholders and health authorities on regulatory matters.

Skills

Attention to detail

Team player

Understanding local Guidelines

2-3 years RA experience

Education

Bachelor of Pharmacy, Pharmaceutical Science

Job description

Abbott is seeking a Senior Regulatory Affairs Portfolio Manager in South Africa to lead regulatory strategy and compliance for product portfolios. You will ensure submissions align with global standards, manage NMRA registrations, and drive timely product approvals with cross-functional partners.

You will guide regulatory intelligence, oversee quality systems, and mentor RA staff while liaising with internal departments to support business objectives and product launches.