Regulatory Affairs Portfolio Manager

Are you ready to shape the regulatory landscape for life-saving medicines in South Africa? Join us in a role where your expertise will directly influence how patients living with serious chronic diseases gain timely access to the treatments they need. If you're passionate about regulatory excellence and want to be part of a team driving real impact, read on and apply today.

Please note that this position is Office Based (5 days/ week) in our Johannesburg office.

Your new role
As our new Regulatory Affairs Portfolio Manager, you will play a key role in compiling, submitting and securing approval for New Drug Applications (NDA) and Life Cycle Management (LCM) licences, while ensuring that Novo Nordisk remains fully compliant with the evolving South African regulatory environment. Working under the supervision of the RA Manager, you will be a trusted partner across the affiliate and a credible voice with local Health Authorities.

Your day-to-day responsibilities will include:

• Monitoring the local regulatory environment, maintaining records on legislation, guidelines and Health Authority (HA) requirements, and ensuring full compliance with internal SOPs


• Compiling, preparing and submitting regulatory documents and dossiers to support new product registrations, renewals, variations and post-approval activities


• Interacting with Health Authorities to secure timely approvals, respond to queries and stay ahead of regulatory trends


• Supporting the development, review and update of labelling materials and reviewing promotional materials to ensure legal and regulatory compliance


• Preparing and submitting Section 36 exemptions, renewal applications and supporting tender applications as required


• Updating the Special Delivery List (SDL) in the regulatory system, maintaining archival systems and writing or updating relevant SOPs


• Deputising for the RA Manager and the Responsible Pharmacist during their absence, and sharing regulatory intelligence proactively with Marketing, Legal, Logistics and Sales

Your new department
As part of International Operations, you will join our largest operational unit. Covering 194 countries and 95% of the world's population, more than 18,000 of us work passionately to serve 35 million patients each day. With a promise to outperform the competition, we continue to be the growth driver for Novo Nordisk, and to improve health at scale across the globe.

Within our South Africa affiliate, you will join a close-knit Regulatory Affairs team reporting to the Head of RA/PV and Responsible Pharmacist, with a dotted line to BAMEAC RA. We collaborate closely with cross-functional colleagues and external stakeholders to ensure that patients in South Africa benefit from a steady supply of approved, compliant and high-quality Novo Nordisk products.

Your skills & qualifications
We're looking for a regulatory professional who combines technical expertise with strong stakeholder skills and a proactive mindset. To succeed in this role, you'll bring with you:

• A university degree, with a current B. Pharm degree is required


• A minimum of 5 years' experience in Regulatory Affairs within the pharmaceutical industry


• Solid knowledge of local South African legislation and Health Authority requirements, with proven experience compiling and submitting NDA and LCM dossiers


• Strong stakeholder management skills and the ability to build trusted relationships with Health Authorities, pharmaceutical associations and cross-functional colleagues in Marketing, Legal, Logistics and Sales


• A proactive, solutions-oriented approach with the ability to navigate change, share regulatory intelligence and make things happen in a complex environment


• Excellent written and verbal communication skills in English, with a high attention to detail in reviewing translations, labelling and promotional content

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

Please apply by June 24th, 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.