Experienced Cross Regional Regulatory Professional
Johnson & Johnson Innovative Medicine
São Paulo, Brazil
Regulatory requirements
Submission document review
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.
Assists in the preparation of meetings with Regulatory Agencies and supports regional and local activities.
Responsible for the critical review of submission documents to ensure compliance with regulatory requirements and provides regulatory support for inspections, audits, and product complaints.
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 document review
lifecycle management
regional regulatory strategy
Health Authority interactions
Nice-to-have
intellectual curiosity
results and performance driven
collaboration and teaming
analytical thinking
self awareness and adaptability
Key Requirements
2 years relevant experience
B.A./B.S. in science/relevant health-related discipline
Excellent English verbal and written communication skills