LATAM Regulatory Affairs: Lifecycle Submissions Expert

Johnson & Johnson Innovative Medicine; Municipio de Esquel; On-site; ARS 128,848,000 - 166,745,000; Full time

Job summary

Johnson & Johnson Innovative Medicine seeks an experienced Regulatory Affairs professional to drive end-to-end lifecycle management for LATAM post-registration activities across Chile, Argentina, and nearby countries.

The role emphasizes accurate dossier preparation, timely variations submissions, and robust responses to Health Authorities, in close collaboration with local RA teams and cross-functional partners.

Qualifications

• Bachelor’s degree in Pharmacy or Biological Sciences is required.
• Proactive team player with ability to adapt to regulatory changes.
• Experience with regulatory lifecycle management (LCM) and post-registration variations.

Responsibilities

• Prepare submission-ready dossiers based on local requirements and J&J standards.
• Ensure timely assessment, submission and approval of lifecycle variations.
• Monitor regulatory submissions and approvals.
• Serve as the first point of contact for LCM with local RA colleagues.
• Handle Health Authority queries for LCM submissions with stakeholders.
• Collaborate with local team across countries in scope.

Skills

Regulatory submissions

Data analysis

RA systems

Biologics experience

Spanish language

English language

Education

Bachelor’s degree in Pharmacy or Biological Sciences

Tools

RA databases

Job description

Johnson & Johnson Innovative Medicine seeks an experienced Regulatory Affairs professional to drive end-to-end lifecycle management for LATAM post-registration activities across Chile, Argentina, and nearby countries.

The role emphasizes accurate dossier preparation, timely variations submissions, and robust responses to Health Authorities, in close collaboration with local RA teams and cross-functional partners.