RA Lead

Bachelor of Pharmacy Degree
Minimum 5 years experience in a Regulatory Affairs environment, including submission and management of new product applications, and variations in accordance with the latest requirements - this is essential
Minimum 1 year management experience in a Regulatory environment
Project management experience
Support South African commercial business to achieve annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio
Ensuring successful variation approval from SAHPRA
Actively coordinate, manage and implement regulatory requirements for the Regulatory Variation Plan
Manage submissions to SAHPRA, including submissions portals and/or eCTD publishing
Updates to artwork for technical changes
Comprehensive knowledge of SAHPRA and SADC Guidelines