Job Description

Responsible for new Product Applications



Compilation and submission of Post Registration amendments to ensure dossier compliance.



Responsible for pre and post registration SAHPRA Committee recommendation responses to ensure Product registration



Responsible for dossier updates, PI/PIL updates to ensure compliance with current legislation



Approval of master batch documentation prior to product production



Responsible for SOP implementation/review, update and compliance



Managing and maintaining Regulatory documentation filing system



Ensuring Regulatory compliance and quality related records are available and retained



Ensure on-going Regulatory compliance of the existing product portfolio



Ensure awareness of legislative changes and trends that will impact the core function of the regulatory affairs department and hence the marketability of Company products



Liaise with Business development for Regulatory requirements prior to dossier acquisition



Training and peer review of documents



To ensure approval and compliance of printed packaging material and promotional marketing material.



Liaising with Marketing department to facilitate timeous launch of products



Building and maintain effective working relationships with both the South Africa and India Regulatory teams



Ability to interpret complex information, coupled with excellent time management skills



High attention to detail and excellent writing skills



Advanced MS Office



Completed Bachelor of Pharmacy degree



Registration with the SAPC as a Pharmacist



5+ years' experience as Regulatory Affairs Pharmacist



Strong knowledge of Regulatory/Quality activities in the South African Pharma industry



Between 5 - 7 Years