Regulatory Affairs Manager - Ernest Chemists Limited

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