LATAM Regulatory Submissions Leader – Lifecycle

Biopharma Careers; Buenos Aires; Híbrido; ARS 1 200 000 - 2 400 000; Tempo integral

Resumo da oferta

Johnson & Johnson is seeking an Experienced Regulatory Affairs Professional for LATAM to lead end-to-end lifecycle management in Argentina, Chile, Uruguay, Paraguay, Bolivia, and other LATAM countries. You will handle post-registration variations and ensure timely submissions in line with local regulations.

The role requires a Bachelor’s degree in Pharmacy or Biological Sciences, 3–4 years regulatory experience, and strong collaboration across RA, Supply, CQ, and other teams.

Qualificações

• Bachelor's degree in Pharmacy or Biological Sciences is required.
• 3–4 years regulatory experience in pharmaceuticals.
• Proficient in Spanish; Advanced English is required.
• Experience with biological products and labeling updates is required.
• Experience working in virtual/global teams.

Responsabilidades

• Prepare submission-ready dossier based on local requirements and J&J standards.
• Ensure assessment, submission and approval of life cycle variations in a timely manner.
• Monitor regulatory submissions/approvals.
• Be first point of contact for LCM with the local Regulatory Affairs colleagues.
• Coordinate with RA, Supply, CQ, AW responsible, etc. across countries in scope.
• Responsible for RA databases related to LCM; archiving all relevant documents.
• Participate in meetings with different departments, contributing regulatory knowledge.
• Assess impacts of new legislation and develop robust implementation plans.

Conhecimentos

Regulatory submissions

Lifecycle management

Cross-functional collaboration

Regulatory intelligence

Data-driven decisions

Spanish language

English language

Formação académica

Bachelor’s degree in Pharmacy or Biological Sciences

Descrição da oferta de emprego

Johnson & Johnson is seeking an Experienced Regulatory Affairs Professional for LATAM to lead end-to-end lifecycle management in Argentina, Chile, Uruguay, Paraguay, Bolivia, and other LATAM countries. You will handle post-registration variations and ensure timely submissions in line with local regulations.

The role requires a Bachelor’s degree in Pharmacy or Biological Sciences, 3–4 years regulatory experience, and strong collaboration across RA, Supply, CQ, and other teams.