Regulatory Affairs Pharmacist – Pharmaceutical Company (Gauteng) 24 views
Job Overview
The Regulatory Pharmacist if responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market
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
Minimum Requirements
- 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
