Experienced Regulatory Affairs Professional – Lifecycle Submissions LATAM
Johnson & Johnson Innovative Medicine · Buenos Aires
Descripcion del puesto
About the role
Johnson & Johnson is seeking an experienced Regulatory Affairs professional to manage end‑to‑end lifecycle submissions across several LATAM markets. The role focuses on post‑registration variations, ensuring compliance and timely approvals.
Key responsibilities
- Prepare submission‑ready dossiers according to local requirements and J&J standards.
- Execute and monitor lifecycle variation submissions, handling health authority queries.
- Maintain regulatory databases, archive documents, and ensure alignment with local RA, supply, and quality teams.
- Assess impact of new legislation and develop implementation plans.
Required profile
- Bachelor’s degree in Pharmacy or Biological Sciences.
- 3‑4 years of regulatory experience in the pharmaceutical industry, preferably with biological products.
- Proactive, adaptable, and able to work in virtual/global teams.
- Fluent in Spanish and advanced English.
Required skills
- Regulatory affairs systems (RA databases, submission platforms).
- Labeling updates and package design knowledge.
- Data gathering and analysis for regulatory decisions.
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Johnson & Johnson Innovative Medicine
Buenos Aires
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