Regulatory Affairs Analyst (Región Metropolitana)

Regulatory Affairs Analyst (fixed-term contract) Category: Reg Affairs & Safety Pharmacovigilance Location: Santiago, Región Metropolitana, CL Regulatory Affairs Department Play a crucial role in bringing life-changing medicines to Chilean patients through regulatory excellence in this 8-month opportunity. Your 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 general strategy and local implementation. Your responsibilities
- 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 skills & qualifications
- 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 p Postúlate en Kit Empleo: kitempleo.cl/empleo/1dwt0b