Experienced Cross Regional Regulatory Professional
J&J FAMILY OF COMPANIES
São Paulo, Brazil
Regulatory requirements
Submission dossier components
Lifecycle management
Provides support to the C-ROSS(MS) Product Leader and Regulatory Regional Leader for regulatory activities for products in the assigned portfolio
Job Summary
Provides support to the C-ROSS(MS) Product Leader and Regulatory Regional Leader for regulatory activities for products in the assigned portfolio.
Responsible for the critical review of submission documents to ensure compliance with regulatory requirements and provides regulatory support for inspections, audits, and product complaints.
Supports all regulatory activities associated with the development, post-approval and life-cycle management for designated products.
Matching Summary
Provides support to the C-ROSS(MS) Product Leader and Regulatory Regional Leader for regulatory activities for products in the assigned portfolio.
Skills & Requirements
Must-have
regulatory requirements
submission dossier components
lifecycle management
Health Authority operations
therapeutic area knowledge
Nice-to-have
results and performance driven
analytical thinking
communication skills
concern for quality and order
intellectual curiosity
Key Requirements
B.A./B.S. in science/relevant health-related discipline
2 years relevant experience (Senior Associate level)
Excellent English verbal and written communication skills