Strategic Regulatory Portfolio Manager

ZA01 (FCRS = ZA001) Novartis SA (Pty) Ltd.; Midrand; On-site; ZAR 1,200,000 - 1,600,000; Full time

Job summary

Novartis SA (Pty) Ltd in South Africa is seeking a Regulatory Affairs Portfolio Manager to oversee a portfolio of pharmaceutical products, guiding regulatory lifecycle from planning to submission and compliance with local requirements. You will partner with Medical, Quality, Supply Chain, and external authorities to secure timely approvals, maintain licenses, and implement regulatory strategies aligned with global goals.

English required; B.Pharm.

Qualifications

• Regulatory knowledge of SA legislation and SAHPRA processes.
• Strong project planning and prioritization skills.
• Attention to detail and dossier quality.

Responsibilities

• Develop and execute regulatory plans for new registrations, variations, renewals, safety updates, and dossier maintenance activities.
• Support accelerated approvals, line extensions, new indications, and product launches.
• Maintain current product licenses and ensure alignment with global regulatory strategy.

Skills

Regulatory knowledge SA regulations

Project management

Stakeholder management

Attention to detail

eCTD knowledge

Cross-functional collaboration

Education

B.Pharm. Registration with SAPC

Tools

Regulatory Information Management systems

eCTD processes

Regulatory databases

Job description

Novartis SA (Pty) Ltd in South Africa is seeking a Regulatory Affairs Portfolio Manager to oversee a portfolio of pharmaceutical products, guiding regulatory lifecycle from planning to submission and compliance with local requirements. You will partner with Medical, Quality, Supply Chain, and external authorities to secure timely approvals, maintain licenses, and implement regulatory strategies aligned with global goals.

English required; B.Pharm.