Regulatory Affairs Pharmacist at GB Pharma Limited – APPLY HERE

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Reporting to the country Superintendent Pharmacist, the Regulatory Affairs Pharmacist 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 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 a 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 the FDA, Ghana standards board, Pharmacy council and associated regulatory bodies.
  • Microsoft Office proficiency
  • Fluency in French is preferred.

The 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

Location

  • Accra

      Method of Application

Interested and qualified applicants to send a motivational statement and CV to: ibatra@gbpharma.co.uk

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