LATAM Regulatory Submissions Lead, Lifecycle

Johnson & Johnson Innovative Medicine; Tandil; On-site; ARS 83,266,000 - 128,685,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking a Regulatory Affairs Professional to manage lifecycle submissions across LATAM, focusing on post-registration variations in Chile, Argentina, Uruguay, Paraguay, Bolivia, and beyond.

The role emphasizes end-to-end lifecycle management, dossier accuracy, timely submissions, and regulatory compliance, with collaboration across regional teams and stakeholders.

Qualifications

• Bachelor’s degree in Pharmacy or Biological Sciences is required.
• Approximately 3–4 years of regulatory experience in the pharmaceutical industry.
• Experience working in a virtual team and/or global organization.
• Strong data gathering and interpretation with proficient use of RA systems.
• Previous experience with biological products and labeling updates is required.

Responsibilities

• Prepare submission-ready dossiers based on local requirements and J&J standards.
• Ensure timely assessment, submission and approval of life cycle variations.
• Monitor regulatory submissions/approvals for LATAM.
• Be first point of contact for LCM with local RA colleagues.
• Handle Health Authority queries for LCM submissions with stakeholders.
• Coordinate with local teams (RA, Supply, CQ, AW) across countries in scope.
• Manage RA databases related to LCM.
• Archive all documents from submissions and approvals.
• Participate in cross-department meetings and contribute regulatory knowledge.
• Assess impacts of new legislation and develop robust implementation plans.

Skills

Regulatory submissions

Lifecycle management

Cross-country regulation

Education

Pharmacy or Biological Sciences degree

Tools

RA systems

Job description

Johnson & Johnson Innovative Medicine is seeking a Regulatory Affairs Professional to manage lifecycle submissions across LATAM, focusing on post-registration variations in Chile, Argentina, Uruguay, Paraguay, Bolivia, and beyond.

The role emphasizes end-to-end lifecycle management, dossier accuracy, timely submissions, and regulatory compliance, with collaboration across regional teams and stakeholders.