Executive or Sr. Executive Regulatory Affairs Brazil
4 weeks ago
Location: For two years in Brazil Office followed by Office in Mumbai
Job description
Responsibilities
Ensure change management, post approval changes to ANVISA
Review of technical documents for new submissions, post approval changes (Individual Protocol, HMP).
Writing PATE for post approval changes
Respond to technical deficiencies received from ANVISA
Maintain department records as assigned.
Application for Good Manufacturing Practices to ANVISA
Coordination of Pharmaceutical and Analytical Testing laboratory and Clinical Research Organization for PE and BE studies.
Coordination with ANVISA for technical queries
Desired Skills
Complete knowledge of ANVISA regulatory guidance
Proficient in new product submissions for solid oral dosages, parental/sterile formulations to ANVISA
Reading/Writing Portugal language preferred or willing to learn the language.
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