Regulatory Affairs Specialist

Regulatory Affairs Department

Región Metropolitana de Santiago

Are you ready to own the regulatory lifecycle of medicines that are transforming how millions of people manage diabetes and obesity? Join us in Chile and help bring innovative therapies to patients faster.

Your new role

As our Regulatory Affairs Specialist, you'll take full ownership of the Chilean regulatory portfolio – managing every stage from initial registration to modifications, notifications, and discontinuations before the ISP. You'll work hands-on with biotechnological products and diabetes therapies, including semaglutide/GLP-1, while staying connected to global teams that are redefining what's possible in healthcare.

Here's what your day-to-day will look like:

• Leading product registrations, modifications, and regulatory notifications before the ISP from start to finish
• Managing the regulatory lifecycle of biotechnological products and GLP-1/semaglutide-associated therapies
• Keeping regulatory platforms up to date – including GICONA – ensuring data accuracy and compliance at all times
• Collaborating daily with global regulatory teams to align local submissions with international strategies
• Preparing and submitting dossiers in CTD format in full compliance with Chilean regulatory requirements
• Managing product discontinuations when needed, ensuring all regulatory obligations are fulfilled

Your new department

You'll be joining the Regulatory Affairs Department in Chile – an agile team that sits at the crossroads of local expertise and global innovation. We're the ones making sure our growing portfolio of transformative therapies navigates the regulatory landscape smoothly and reaches patients on time. If you enjoy working in a collaborative, fast-moving environment where your contributions are visible and valued, this is the place for you.

Your skills & qualifications

We're looking for someone who's curious, proactive, and energised by the idea of keeping a dynamic portfolio compliant and growing. Here's what you'll need:

• Pharmacy degree recognized in Chile
• Minimum 4 years of experience in Regulatory Affairs within the pharmaceutical industry (pharmaceuticals or medical devices)
• Proven track record in registrations and modifications of biotechnological products
• Hands-on experience with the ISP's GICONA platform
• Solid knowledge of Chilean regulatory legislation and experience with CTD-format submissions
• Familiarity with regulatory systems and packaging material management
• Advanced English – you'll use it daily in trainings, communications, and collaboration with global teams

Working at Novo Nordisk

We're a company with over 100 years of history, but we don't act like it. Every day, we show up with curiosity, energy, and the drive to defeat serious chronic diseases. We believe great things happen when talented people come together with a shared purpose – and we back that up with real investment in your growth, your wellbeing, and your career. Here, diverse perspectives aren't just welcome; they're what make us better. When you join Novo Nordisk, you become part of something meaningful – a team that's creating lasting change for long-term health, one bold step at a time.

What we offer

More than just a role – you'll find a workplace where learning never stops and your development matters as much as your deliverables. As part of a global healthcare company, you'll have access to opportunities that stretch well beyond borders, alongside benefits designed to support you at every stage of your career and life.

Deadline

30 August 2026. Applications are reviewed on an ongoing basis.

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

We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.