Job Description

To assist with pharmaceutical activities and ensure compliance with applicable legislation, including the compilation of technical information for local and export markets, providing support for product registration, assist with legal compliance and the approval of labelling and advertising material, and to assist with the generation and life cycle management of CTD dossiers.





Responsibilities:


Provide supportive data and information on formulation and registration requirements for local, third party and international markets.

Support the monitoring of legislative trends to identify and or anticipate potential product problems and advise on "early warning" basis.

Review and provide feedback on the legal compliance of packaging artwork and advertising material.

Research literature to compile literature reviews, professional information, patient information leaflets and all other relevant documentation in support of product compliance.

Assist to compile and submit CTD dossiers to the SA Health Products Regulatory Authority (SAHPRA) in line with relevant timeframes.

In conjunction with the RA Manager / RA Pharmacist, provide information of a medical or pharmacological nature in response to queries from customers.

Update and maintain SOP's relevant to RA Department.

Review and ensure compliance of QA documents with the relevant legislation and guidelines, e.g., raw material and finished product specifications, stability protocols/reports, product quality reviews, etc.

Support the approval process of new and/or revised master manufacturing and packaging documents.

Maintain cordial relations with the SAHPRA and the Department of Health.


BSc. Natural Sciences / Post Basic Pharmacist Assistant.

Computer literacy (MS Word, MS Excel, Powerpoint).

* At least 2 years pharmaceutical experience.