We are seeking an experienced Regulatory Affairs Manager to support a long-term regulatory outsourcing program for pharmaceutical products and medical devices across Latin America. The role is responsible for managing local registrations, product lifecycle maintenance, regulatory intelligence, health authority interactions, and QMS compliance support across multiple target markets in a integral virtual collaboration setting.

Mandatory Language Requirements

- English (Professional Working / Basic Communication): Essential for daily project communications, cross-border client collaboration, virtual project meetings, and global reporting.
- Spanish: Professional fluency in written and spoken Spanish required: Required for preparing dossiers, reviewing local artwork/IFUs, interacting with regional health authorities, and executing local regulatory submissions.

KEY RESPONSIBILITIES

Pharmaceutical Regulatory Operations

- Monitor local regulatory intelligence and assess impact on client product portfolios.
- Compile, review, format, and submit pharmaceutical dossiers and variations.
- Coordinate notarizations, legalizations, Free Sale Certificates (FSCs), and translations.
- Manage follow-ups with Competent Authorities and prepare formal query responses.
- Perform local labeling, artwork, packaging, and advertising compliance checks.
- Maintain QMS working instructions and support health authority inspections/audits

Medical Device Regulatory Operations





- Develop country-specific device registration roadmaps and regulatory pathways.
- Execute gap assessments, device classifications, and administrative submission filings.
- Review technical labeling, Instructions for Use (IFU), and promotional materials.
- Manage license renewals, engineering/CMC variations, and lifecycle maintenance.
- Coordinate with legal manufacturers, distributors, and local authorized representatives.
- Maintain tracking databases, sample submissions, and regulatory fee processes.

REQUIRED EXPERIENCE & EDUCATION

- Experience: 5–10 years in Regulatory Affairs for pharmaceuticals and/or medical devices.
- Education: Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or Regulatory Affairs. Advanced certifications preferred.
- Competencies: Dossier preparation, project management across multiple concurrent regional timelines, and agency liaison expertise.

TARGET REGIONAL SCOPE

Proven regulatory experience supporting Latin American and regional emerging markets is required:

- Experience managing multi-country regulatory submissions, health authority interactions, product renewals, variations, and local compliance requirements across Central America, South America, and the Caribbean markets.

Job Types: Full-time, Contract

Job Types: Full-time, Contract

Pay: $24,000,000 - $30,000,000 per year

Work Location: Hybrid remote in Chile Chico, Aisén

📌 Regulatory Affairs Manager (Chile Chico)
🏢 Artixio Lifesciences
📍 Chile Chico