Postúlate en Kit Empleo: kitempleo.cl/empleo/1ac40j

Regulatory Affairs Department

Play a crucial role in bringing life-changing medicines to Chilean patients through regulatory excellence in this 8-month opportunity.

Your new role

As a Regulatory Affairs Analyst, you'll be instrumental in ensuring our products meet all regulatory requirements while supporting the timely delivery of treatments to patients.

You'll manage the complete lifecycle of regulatory documentation and serve as a key link between integral strategy and local implementation.

Your responsibilities will include:

- Managing labelling activities end-to-end, including the preparation, update and submission of packaging and labelling changes to the local Health Authority, in compliance with local legislation, HQ requirements and internal SOPs.
- Ensuring post-approval implementation of labelling approved changes, coordinating accurate and timely execution through the Lift system across the product portfolio.
- Supporting tender processes by managing requests for legal documents (CPP, GMP) and providing required documentation
- Supporting Life Cycle Management (LCM) activities, including variations related to labelling, safety updates, new sites and other regulatory changes, ensuring timely submissions and follow-up.
- Supporting selected activities related to New Drug Application (NDA) registrations, such as dossier preparation and submission follow-up, as part of the overall Regulatory Affairs team activities.




- Communicating product updates and maintaining shared repositories to ensure all stakeholders have access to current information

Your new department

Within our Chilean affiliate, the Regulatory Affairs team plays a vital role in translating global and regional strategies into local regulatory success.

Working closely with cross-functional teams, you'll help ensure our expanding portfolio reaches patients while maintaining the highest standards of compliance and quality.

Your skills & qualifications

We're looking for a regulatory professional who combines technical expertise with attention to detail and strong stakeholder collaboration skills.

You'll bring:

- Minimum 2 years of regulatory affairs experience in the pharmaceutical industry (mandatory)
- Advanced English proficiency, both written and verbal (mandatory)
- Degree in Pharmaceutical Chemistry (Químico Farmacéutico) (mandatory)
- In-depth knowledge of Chilean pharmaceutical regulations and regulatory processes (mandatory)
- Strong understanding of pharmaceutical business operations and lifecycle management
- Excellent organizational skills with the ability to manage multiple regulatory submissions and deadlines simultaneously
- Proven ability to work effectively with cross-functional teams and communicate complex regulatory requirements clearly

Required Skill Profession

Business Operations Specialists

Postúlate en Kit Empleo: kitempleo.cl/empleo/1ac40j

📌 Regulatory Affairs Analyst (fixed term contract) (Santiago)
🏢 Novo Nordisk A/S
📍 Santiago