Experienced Regulatory Affairs Professional – Lifecycle Submissions LATAM

Johnson & Johnson Innovative Medicine · Buenos Aires

New

Mid 🇬🇧 English

Labeling updates

Job description

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.

Questions fréquentes

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Published 1 day ago

Expires 1 month from now

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Johnson & Johnson Innovative Medicine

Buenos Aires

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