LATAM Regulatory Affairs Lead: Lifecycle Submissions

Showup Studios; Quilmes; On-site; ARS 90,873,000 - 121,164,000; Full time

Job summary

Johnson & Johnson is recruiting an Experienced RA Professional Lifecycle Submissions LATAM to join Cross-Regional Operations & Strategy Support (C-ROSS). You will manage end-to-end regulatory lifecycle management, focusing on post-registration variations across LATAM countries, ensuring accuracy, timely submissions and approvals, and maintaining compliance with local regulations.

Responsibilities include preparing submission-ready dossiers, responding to authority queries, archiving documents,

Qualifications

• Bachelor's degree in Pharmacy or Biological Sciences required.
• Approximately 3–4 years of regulatory experience in pharmaceuticals.
• Proficiency in Spanish; Advanced English required.
• Experience with regulatory lifecycle management and post-registration variations.

Responsibilities

• Prepare submission-ready dossier based on local requirements and J&J standards and procedures.
• Ensure assessment, submission and approval of life cycle variations in a timely manner.
• Monitoring of Company regulatory submissions/approvals.
• Be first point of contact for LCM with the local Regulatory Affairs colleagues.
• Handle any Health Authority query for LCM submissions with applicable stakeholders, ensuring the robustness of the response.
• Continuous communication, integration and alignment with local team (i.e. RA, Supply, CQ, AW responsible, etc) of the countries in scope.
• Responsible for RA databases related to LCM.
• Archiving all relevant documents from submissions and approvals.
• Participate in meetings with different departments, contributing and adding knowledge.
• Assessment of the impacts of new legislation, risks and opportunities and develop a robust plan for implementing new legislation.

Skills

Regulatory submissions

Spanish

English

Regulatory compliance

Data interpretation

Education

Bachelor's degree in Pharmacy or Biological Sciences

Tools

RA systems

Dossier preparation tools

Job description

Johnson & Johnson is recruiting an Experienced RA Professional Lifecycle Submissions LATAM to join Cross-Regional Operations & Strategy Support (C-ROSS). You will manage end-to-end regulatory lifecycle management, focusing on post-registration variations across LATAM countries, ensuring accuracy, timely submissions and approvals, and maintaining compliance with local regulations.

Responsibilities include preparing submission-ready dossiers, responding to authority queries, archiving documents,