- Company: GB Pharma Limited
- Location: Ghana
- State: Accra
- Job type: Full-Time
- Job category: Healthcare Jobs in Ghana
Reporting to the country Supintendent Pharmacist, the Regulatory Affairs Pharmacist will manage a variety of regulatory and administrative processes.
- 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
Method of Application Interested and qualified applicants to send a motivational statement and CV to: firstname.lastname@example.org