Job Description

Key purpose:

To fulfill the position as regulatory affairs pharmacist for the company and any division within the group.

Duties and responsibilities:

• 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
• 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.
• 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

Qualifications and experience:

• Bachelor of Pharmacy Degree
• Minimum 2 years experience in regulatory affairs in any regulated regions e.g., South Africa Europe, UK, Australia, Canada, Japan
• Attention to detail
• Pharmacovigilance is an advantage
• 2 Years experience in regulatory affairs and attention to detail

Skills and competencies:

• Docubridge
• Sage
• Smartsheet
• Sweet process
• Microsoft: Excel, Word, PowerPoint, Outlook