Regulatory Affairs Pharmacist at GB Pharma Limited

Job responsibilities:

• Compile and prepare registration dossiers for submissions and responses to regulatory bodies
• Manage regulatory submissions with FDA Ghana
• Establish effective relationships with all stakeholders
• Ensure fast approval of registration applications and variations for all products
• Ensure timely maintenance/ update of registrations
• Perform QA on all artwork and approve all printed packaging material
• Act as lead QPPV and manage pharmacovigilance processes
• Ensure compliance with all pharma related regulatory bodies in Ghana
• Oversee regulatory inspections
• Keep up to date with changes in regulatory legislation and guidelines
• Maintain familiarity with company product ranges
• Outline requirements for labelling, storage and packaging
• Ensure that quality standards are met and submissions meet strict deadlines
• Maintain regulatory files / database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted and maintain product technical files
• Training staff and ensuring regulatory compliance

Experience & Qualifications required:

• 3+ years of experience in a similar position
• Advance degree with at least B. Pharm from a top recognised university
• QPPV with FDA Ghana
• Experience in dealing with FDA, Ghana standards board, Pharmacy council and associated regulatory bodies.
• Microsoft office profficiency
• Fluency in French is preferred.

Ideal candidate will have:

• Good analytical, organizing and communication skills.
• Ambitious, self-starter, able to work independently
• Ability to work to strict deadlines
• Ability to handle multiple projects simultaneously.
• Understanding of both legal and scientific matters
• Strong negotiation and influencing skills