LATAM Regulatory Affairs: Lifecycle Submissions Expert

Johnson & Johnson Innovative Medicine; Santiago; On-site; CLP 59,113,000 - 88,670,000; Full time

Job summary

Johnson & Johnson Innovative Medicine is seeking an Experienced Regulatory Affairs Professional to manage end-to-end lifecycle submissions across LATAM, with focus on post-registration variations and country registrations.

The role collaborates with cross-regional teams in Chile, Argentina, Uruguay, Paraguay, Bolivia, and other LATAM countries to ensure timely submissions, compliant dossiers, and robust responses to Health Authority queries.

Qualifications

• Approximately 3-4 years of regulatory experience in the pharmaceuticals industry.
• Experience with biological products and labeling updates is required.
• Proficient in Spanish; Advanced English is required.
• Experience working in a virtual team and/or global organization.

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 within LATAM countries.
• Act as first point of contact for LCM with local Regulatory Affairs colleagues.
• Handle Health Authority queries for LCM submissions with stakeholders.
• Coordinate with local teams (RA, Supply, CQ, AW) across countries in scope.
• Maintain RA databases related to LCM and archive relevant documents.
• Participate in cross-department meetings, contributing regulatory insights.
• Assess impacts of new legislation and develop implementation plans.

Skills

Regulatory submissions

Lifecycle management

Cross-functional teamwork

Data-driven decision making

Analytical thinking

Education

Bachelor’s degree in Pharmacy or Biological Sciences

Tools

RA systems

Job description

Johnson & Johnson Innovative Medicine is seeking an Experienced Regulatory Affairs Professional to manage end-to-end lifecycle submissions across LATAM, with focus on post-registration variations and country registrations.

The role collaborates with cross-regional teams in Chile, Argentina, Uruguay, Paraguay, Bolivia, and other LATAM countries to ensure timely submissions, compliant dossiers, and robust responses to Health Authority queries.