Regulatory Affairs Pharmacist

About the job Regulatory Affairs Pharmacist

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

• 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 timely 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.

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

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