LATAM Regulatory Affairs Lead - Submissions & LCM

Showup Studios; Quilmes; Remote; ARS 90,873,000 - 136,310,000; Full time

Job summary

Johnson & Johnson is recruiting for an Experienced RA Professional Lifecycle Submissions LATAM to work in Cross-Regional Operations & Strategy Support (C-ROSS). This role manages end-to-end regulatory lifecycle management in LATAM, focusing on post-registration variations and ensuring timely submissions and approvals across several countries.

You will collaborate with local RA colleagues, monitor submissions, handle queries, and maintain RA databases.

Qualifications

• Bachelor's degree in Pharmacy or Biological Sciences is required.
• Approximately 3-4 years of regulatory experience in pharmaceuticals industry.
• Proactive team player, able to take charge and follow-through.
• Experience of working in a virtual team and/or global organization.
• Strong in data gathering and interpretation with proficient use of technology including RA systems.
• Previous experience with biological products and labeling updates is required.

Responsibilities

• Prepare submission-ready dossier based on local requirements and J&J standards and procedures.
• Ensure assessment, submission and approval of lifecycle variations in a timely manner.
• Monitoring of Company regulatory submissions/approvals.
• Be first point of contact for LCM with local Regulatory Affairs colleagues.
• Handle Health Authority queries for LCM submissions with applicable stakeholders.
• Coordinate with local team across RA, Supply, CQ, AW and other stakeholders.

Skills

Regulatory experience

Spanish language

English language

Team collaboration

Data analysis

Education

Bachelor's degree in Pharmacy or Biological Sciences

Tools

RA systems

Job description

Johnson & Johnson is recruiting for an Experienced RA Professional Lifecycle Submissions LATAM to work in Cross-Regional Operations & Strategy Support (C-ROSS). This role manages end-to-end regulatory lifecycle management in LATAM, focusing on post-registration variations and ensuring timely submissions and approvals across several countries.

You will collaborate with local RA colleagues, monitor submissions, handle queries, and maintain RA databases.