Ernest Chemists Limited

  • Accra
  • Ernest Chemists Limited
Job Description:

  • Our client is the leading pharmaceutical company in Ghana. The company now seeks a hands-on Regulatory Affairs Manager to be based in its Accra Offices, overseeing the day-to-day Operations in Accra.

    Key Accountabilities

    • Ensure products meet current international requirements.
    • Develop proposals for acquisition of new product licenses, registration or renewal.
    • Monitor and set timelines for license variations and renewal approvals.
    • Submit returns on controlled, psychotropic and narcotic products on time.
    • Liaise with external regulatory authorities and make presentations, respond to queries, negotiate for marketing authorization, review all regulatory compliance materials and properly document all affairs.
    • Ensure company products comply with regulations of Food and Drugs Authority (FDA), Ghana Standards Authority (GSA) and Narcotics Control Board (NACOB).
    • Control the safety and efficacy of products by ensuring appropriate licensing, legal compliance and marketing according to statutory regulatory policies.
    • Keep up to date with national and international legislation, guidelines and customer practices.
    • Liaise with affiliates or suppliers to ensure all imported products follow due process and are compliant.
    • Manage recall of products and prepare recall report.
    • Ensure safe disposal of expired and all non-conforming products.
    • Perform computer system quarantine and release of products.
    • Generation of computer system-based reports for regulatory bodies and other stakeholders.
    • Monitor controlled, psychotropic and narcotic products of the company.

    Qualification Required & Experience

    • Masters in Applied or Medical Sciences, Regulatory Science
    • Minimum 8 years’ experience in a similar role

    Location: Accra

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