Regulatory Affairs Pharmacist at GB Pharma Limited – APPLY HERE

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: [email protected]

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Avatar of Ellis Ferdinand
Ellis Ferdinand is a Journalist, Blogger and Founder of Ellis Multimedia, a parent company of EducationGhana.org, an Online Education News Blog, PoliticsGhana.com and GhanaNaija.net. Ellis Ferdinand is a Graduate of Accra College of Education and the University of Cape Coast, where he obtained a Diploma In Basic Education and a Bachelor of Education in Accounting. He is currently Reading his Master of Philosophy in Curriculum and Pedagogic Studies at the University of Education, Winneba in Ghana. Ellis Ferdinand won Blogger of the Year at the 2018 National Students’ Awards and was also adjudged 14th Best Ghanain Blogger in 2018 among the Top 50 Ghanaian Bloggers of 2018. He introduced the Concept of Education Blogging in Ghana in 2014 with his famous blog EducationGhana.net. now EducationGhana.org His Blog won Best Media Promoting Education in 2017, 2018 and 2019 respectively, an Award organized by Neogenics Education Consult. In 2019, He adjudged the Most Promising West African Blogger of the Year in Nigeria. He won Writer of the Year at the 2021 EDUCOM AWARDS

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