May 13th, 2020 at 12:54 pm
Every day, GB Pharma strive to develop products that can ensure wellness, prevention, treatments and cures that can confront the most feared ailments & diseases of our time. Our journey began in 1991, with the intention to help each patient who is fighting illness by continuously generating innovative and highly beneficial drugs for diseases which high unmet medical needs exist, through continuous efforts in research and development, and providing them. Medicines and their ingredients can be made in facilities all over the world.
JOB DESCRIPTION
Reporting to the country Superintendent Pharmacists, the Regulatory Affairs Pharmacists at GB Pharma Limited will manage a variety of regulatory and administrative processes.
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 pharmacological 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 labeling, 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 recognized university
- QPPV with FDA Ghana
- Experience in dealing with FDA, Ghana standards board, Pharmacy council and associated regulatory bodies.
- Microsoft office proficiency
- 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
HOW TO APPLY FOR THIS JOB
CLICK HERE TO APPLY FOR THIS JOB ONLINE
DEADLINE: Ongoing