Job Description
Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category: Professional
All Job Posting Locations: Buenos Aires, Argentina
Job Summary
As Country Regulatory Affairs Lead, you coordinate regulatory activities across assigned markets, define and implement strategies for NPIs and LCM, manage submissions and post‑approval actions, and keep regulatory and labeling databases current. You lead RA specialists and external consultants, liaise with cross‑functional teams and franchises, represent J&J to health authorities, and monitor regulatory changes to ensure compliant, timely product approvals.
Major Roles and Responsibilities
- Coordinate the regulatory activities in the country (or group of countries) under scope.
- Determine regulatory strategy for NPIs (New Products Introduction) and LCM (Life Cycle Management).
- Execute submi...