Regulatory Affairs Pharmacist, Pharmaceutical Company ...
Glasshouse Recruiting
Nơi làm việc
Johannesburg
Hình thức tuyển dụng
Toàn thời gian
Chi tiết công việc
Introduction
Requirements:
Education
• Bachelor of Pharmacy Degree
Experience
• Minimum 2 years’ experience in regulatory affairs in any regulated regions e.g., South Africa, Europe, UK, Australia, Canada, Japan
Skills / Physical Competencies
• Docubridge
• Sage
• Smartsheet
• Sweet process
• Microsoft: Excel, Word, PowerPoint, Outlook
Behavioural Qualities
• Takes ownership
• Integrity, bound to principles, confidentiality, and ethics
• Strong leadership skills
• Good communication skills
• Good organisational skills
• Good planning skills
• Good follow-up skills
• Attention to detail
• Assertive
• Conscientious
• Patient
• Co-operative
• Deadline Driven
Desirable Skills & Experience
• 2 Years’ experience in regulatory affairs and attention to detail
Duties & 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
