Job Description: Responsibilities & Requirements
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
« Go back to the jobs list
RELATED JOBS >> CLICK A JOB BELOW TO VIEW & APPLY
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
« Go back to the jobs list