Regulatory Affairs Portfolio Manager

Novartis is hiring a Regulatory Affairs Portfolio Manager in Midrand to manage a portfolio of pharmaceutical products through their regulatory lifecycle. The role supports timely patient access, keeps marketing authorisations in place and ensures compliance with local requirements and Novartis standards, acting as the strategic regulatory partner to internal and external stakeholders.

Key responsibilities:

– Secure product registrations with commercially attractive labelling in line with the registration plan

– Plan and run new registrations, variations, renewals, safety updates and dossier maintenance

– Maintain product licences (CMC/CDS/safety updates) in line with local law and global strategy

– Support accelerated approvals, line extensions, new indications and launches

– Ensure compliance for related activities such as RIM updates, RMPs, packaging and promotional materials

– Work with Medical, Quality, Supply Chain, Pharmacovigilance, Commercial and global teams, and build relationships with health authorities

– Report technical complaints and adverse events within 24 hours

Requirements:

– B.Pharm and registration with the SAPC

– 3-5 years’ regulatory affairs experience

– Strong knowledge of South African pharmaceutical legislation and SAHPRA processes

– Project management, prioritisation and attention to dossier quality

– Knowledge of regulatory systems (e.g. RIM, eCTD)

– Fluent English

Posted: 6 October 2026. Workday posting end date: 21 October 2026. Req REQ-10089433.