Executive or Sr. Executive Regulatory Affairs Brazil

Qualifications: B.Pharm/ M. Pharm/ M.Sc.

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.