Regulatory Affairs Manager - Ernest Chemists Limited



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Ernest Chemists Limited Healthcare Jobs in Accra


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Ernest Chemists Limited 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 the regulations of the 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 reports.
  • 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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