- To ensure approval and compliance of printed packaging material and promotional marketing material.
- Liaising with marketing department to facilitate timeous launch of products.
- Approval of master batch documentation prior to product production.
- Responsible for SOP implementation/review, update and compliance.
- Liaise with business development for regulatory requirements prior to dossier acquisition.
- Responsible for anticipating, receiving and submission of new product registrations for a particular financial year.
- Responsible for submission of generic dossiers, NCE’s as well as complimentary medicines.
- 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.
- Ensuring that the company is aware of significant local and international regulatory issues which can impact the business.
- Managing and maintaining regulatory documentation filing system.
- Ensuring regulatory compliance and quality related records are available and retained.
- 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.
- Responsible for Pharmacovigilance monitoring within the group.