Unichem Laboratories Looking for Executive or Sr. Executive Regulatory Affairs Brazil at Mumbai Full Time

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.

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▶️ Executive or Sr. Executive Regulatory Affairs Brazil
🖊️ Unichem Laboratories
📍 Mumbai