Overview
Regulatory Affairs Officer Jobs in Accra, Greater Accra Region, Ghana at Sunda International
Title: Regulatory Affairs Officer
Company: Sunda International
Location: Accra, Greater Accra Region, Ghana
Job Summary
The Regulatory Officer will be responsible for ensuring that all company products comply with the regulatory requirements of the Food and Drugs Authority (FDA Ghana), Ghana Standards Authority (GSA), and other applicable regulatory bodies. The role involves preparing regulatory submissions, supporting compliance with current Good Manufacturing Practices (cGMP), reviewing product documentation, and coordinating regulatory activities across departments.
Key Responsibilities
- Prepare, compile, and submit registration dossiers for new products, product variations, and renewals to the Food and Drugs Authority (FDA Ghana) and Ghana Standards Authority (GSA).
- Monitor and ensure compliance with current Good Manufacturing Practices (cGMP) within the manufacturing facility, including supporting and preparing for regulatory inspections and audits.
- Review product labels, package inserts, artwork, and promotional materials to ensure compliance with FDA regulations and company standards before market release.
- Stay updated on local and international regulatory requirements and assess their impact on company operations and products.
- Collaborate closely with Quality Assurance, Production, and Research & Development teams to ensure technical and regulatory documentation is accurate and up to date.
- Coordinate product recall activities, adverse event reporting, and proper disposal of non-conforming or expired products in compliance with regulatory requirements.
- Maintain organized regulatory records, licenses, certificates, and correspondence with regulatory authorities.
- Support internal regulatory and quality improvement initiatives as assigned by management.
Qualifications & Requirements
- Bachelor’s Degree in Pharmacy, Chemistry, Biochemistry, Microbiology, or a related Life Sciences field.
- Previous experience in regulatory affairs, quality assurance, or pharmaceutical/manufacturing compliance is an added advantage.
- Good understanding of FDA Ghana and GSA regulatory requirements.
- Knowledge of current Good Manufacturing Practices (cGMP) and quality management systems.
- Strong attention to detail and excellent documentation skills.
- Good analytical, organizational, and problem-solving abilities.
- Strong communication and interpersonal skills with the ability to work collaboratively across departments.
- Proficiency in Microsoft Office applications and regulatory documentation systems.
