LATAM Regulatory Submissions Specialist

7425-Janssen Cilag Farmaceutica S.A. Legal Entity; Ciudad de Mendoza; On-site; ARS 90,873,000 - 136,310,000; Full time

Job summary

Johnson & Johnson in Argentina is seeking an Experienced Regulatory Affairs Professional for LATAM lifecycle submissions. You will manage end-to-end post-registration activities across multiple LATAM countries, ensuring compliance and timely updates in variations.

Responsibilities include dossier preparation, submission tracking, and interaction with Health Authorities, while coordinating with RA, Supply, CQ, and other stakeholders in a dynamic, global team.

Qualifications

• Bachelor’s degree in Pharmacy or Biological Sciences is required.
• Approximately 3–4 years of regulatory experience in pharmaceuticals.
• Spanish proficient; English advanced.
• Experience with biological products and labeling updates.

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 and approvals.
• Be first point of contact for LCM with local RA colleagues.
• Handle Health Authority queries for LCM submissions with stakeholders.
• Communicate and align with local teams across scope countries.
• Maintain RA databases related to LCM and archive documents.
• Participate in meetings with departments and contribute knowledge.
• Assess impacts of new legislation and implement plans.

Skills

Analytical Reasoning

Brand Research

Business Behavior

Design Thinking

Detail‑Oriented

Industry Analysis

Market Research

Package and Labeling Regulations

Problem Solving

Process Oriented

Product Packaging Design

Project Management

Project Support

Proof Reading Software

Quality Assurance (QA)

Regulatory Affairs Management

Regulatory Compliance

Risk Assessments

Safety‑Oriented

Education

Bachelor’s degree in Pharmacy or Biological Sciences

Tools

RA systems

Job description

Johnson & Johnson in Argentina is seeking an Experienced Regulatory Affairs Professional for LATAM lifecycle submissions. You will manage end-to-end post-registration activities across multiple LATAM countries, ensuring compliance and timely updates in variations.

Responsibilities include dossier preparation, submission tracking, and interaction with Health Authorities, while coordinating with RA, Supply, CQ, and other stakeholders in a dynamic, global team.