A global biopharmaceutical production company is seeking an SAPC registered Regulatory Affairs Assistant.

Requirements:
Must be SAPC registered as a Post Basic Pharmacist Assistant
2 – 5 Years pharmaceutical/production experience
Knowledge of MCC guidelines and policies
Strong interpersonal skills
Strong analysis and reporting abilities

Responsibilities:
Reporting directly to the Regulatory Affairs Pharmacist
Assisting in managing the life-cycle of the company product brand registrations in accordance with MCC requirements and company SOP’s
Ensuring regulatory compliance for all product brands, line extensions, material source changes etc.
Assist in amendments of printed packaging components
Supporting the QA, NPT, Procurement and Production departments on an ad hoc basis
Keeping abreast of developments and changes within local regulatory environment
Data capturing and maintaining relevant databases
Assisting with presentations of product brand support documents