Regulatory Affairs Manager at Ernest Chemists Limited
We have the largest Job seeker visits by alexa rankings. Post a Job
- Company: Ernest Chemists Limited
- Location: Ghana
- State: Jobs in Accra
- Job type: Full-Time
- Job category: Healthcare Jobs in Ghana
No views yet
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.
• 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
Method of ApplicationAll qualified applicants should send CV directly to: [email protected] indicating the position title on the subject line of the email.
Closing Date: 06 March, 2024
Only shortlisted applicants will be contacted.