Local Candidate Required | Full-Time | On-site, Chile
Department
Regulatory Affairs (RA)
Location
Chile — candidate must be locally based
Reports To
Regulatory Affairs Manager / International RA Team
Employment Type
Full-time
Role Overview
We are looking for an experienced, locally based Regulatory Affairs Specialist to lead pharmaceutical product registration and regulatory strategy in Chile. This role is central to ensuring our products reach the Chilean market efficiently and remain compliant throughout their lifecycle. As the local RA representative, you will act as the primary point of contact with Chilean health authorities and as a critical link between our international team and the local market.
Key Responsibilities
- Manage the complete pharmaceutical product registration process in Chile — from dossier review and submission through to final approval.
- Serve as the primary local liaison with Chilean regulatory authorities (ISP), handling queries, deficiency letters, renewals, and variations.
- Review registration requirements and provide expert regulatory guidance to the international RA team.
- Coordinate the preparation and compilation of required documentation with Manufacturing, QA, RA, and other internal teams.
- Ensure all registrations and submissions are completed within agreed timelines.
- Maintain existing product registrations and manage all post-registration lifecycle activities.
- Provide local Chile market intelligence, including insights on competitors, regulatory developments, distributors, and market opportunities.
- Support the Business Development team in identifying and evaluating products suitable for the Chilean market.
- Monitor changes in Chilean pharmaceutical legislation and proactively flag impacts on the product portfolio.
Requirements
- Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
- Minimum 5 years of pharmaceutical Regulatory Affairs experie