Regulatory Affairs Specialist – Chile

About the role

Join Novo Nordisk in Santiago as a Regulatory Affairs Specialist and take ownership of the Chilean regulatory portfolio for innovative diabetes and obesity therapies. You will manage the full lifecycle of biotechnological products, ensuring timely registrations, modifications, and discontinuations with the Instituto de Salud Pública (ISP).

Key responsibilities

• Lead product registrations, modifications, and regulatory notifications before the ISP from start to finish.
• Maintain the regulatory lifecycle of GLP‑1/semaglutide‑associated therapies.
• Keep regulatory platforms such as GICONA up‑to‑date, ensuring data accuracy and compliance.
• Collaborate daily with global regulatory teams to align local submissions with international strategies.
• Prepare and submit dossiers in CTD format in full compliance with Chilean requirements.
• Manage product discontinuations and fulfill all regulatory obligations.

Required profile

• Pharmacy degree recognized in Chile.
• Minimum 4 years of experience in Regulatory Affairs within the pharmaceutical industry.
• 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 CTD‑format submissions.
• Advanced English for daily communication with global teams.

Required skills

• GICONA platform operation
• CTD‑format dossier preparation
• Chilean regulatory legislation expertise
• Advanced English proficiency

What we offer

• Opportunity to work on transformative therapies for diabetes and obesity.
• Collaboration with global experts in a fast‑moving, visible role.
• Investment in personal growth, wellbeing, and career development.