Regulatory Affairs Portfolio Manager – Johannesburg

About the role

Join Novo Nordisk in Johannesburg as a Regulatory Affairs Portfolio Manager, where you will ensure new drug applications and life‑cycle management licences are compiled, submitted and approved in line with South African regulations. You will work closely with the RA Manager and act as a trusted liaison with local Health Authorities.

Key responsibilities

• Monitor the local regulatory environment, maintain records on legislation, guidelines and Health Authority requirements, and ensure compliance with internal SOPs.
• Compile, prepare and submit regulatory dossiers for new product registrations, renewals, variations and post‑approval activities.
• Interact with Health Authorities to secure timely approvals, respond to queries and stay ahead of regulatory trends.
• Support the development, review and update of labeling and promotional materials to ensure legal and regulatory compliance.
• Prepare and submit Section 36 exemptions, renewal applications and tender support documents as required.
• Update the Special Delivery List (SDL) in the regulatory system, maintain archival systems and author or revise relevant SOPs.
• Deputise for the RA Manager and Responsible Pharmacist during absences and share regulatory intelligence with Marketing, Legal, Logistics and Sales teams.

Required profile

• University degree in a relevant scientific or regulatory discipline.
• Demonstrated experience in regulatory affairs within the pharmaceutical or life‑science sector.
• Strong stakeholder management skills and a proactive, detail‑oriented mindset.

Required skills