Johnson & Johnson seeks an experienced Regulatory Affairs professional for lifecycle submissions across LATAM regions. The role focuses on end-to-end post-registration regulatory management, dossier preparation, and compliance with local and company standards across Chile, Argentina, Uruguay, Paraguay, Bolivia, and other countries.
Responsibilities
Prepare submission-ready dossiers meeting local requirements and company standards
Monitor and ensure timely assessment, submission, and approval of lifecycle variations
Serve as primary contact for lifecycle management with local regulatory colleagues
Handle Health Authority queries and coordinate responses with stakeholders
Maintain regulatory databases and archive submission and approval documentation
Requirements
Bachelor's degree in Pharmacy or Biological Sciences
3-4 years of pharmaceutical regulatory experience
Experience with biological products and labeling updates
Proficient Spanish and advanced English language skills
Strong data gathering and RA systems technology proficiency
Virtual team and general organization work experience

📌 Experienced Ra Professional Lifecycle Submissions Latam (Buenos Aires)
🏢 Johnson & Johnson
📍 Buenos Aires