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Category: Reg Affairs & Safety Pharmacovigilance
Location:
Santiago, Región Metropolitana, CL
Regulatory Affairs Department
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 integral 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 & qualification

📌 Regulatory Affairs Specialist (Santiago)
🏢 Novo Nordisk A/S
📍 Santiago