Regulatory Officer

The Regulatory Officer will be responsible for ensuring that the companys products fully comply with FDA Ghana and other applicable national and international regulatory requirements. The role involves managing product registrations renewals variations regulatory inspections labeling compliance and coordination with Quality Assurance and Quality Control teams.

Tasks

• Prepare submit and track product registration dossiers with the Food and Drugs Authority (FDA) Ghana.
• Supervise and monitor the product registration process through approval.
• Ensure all company products comply with applicable regulatory requirements in Ghana and other target markets.
• Prepare and submit applications for license renewals variations and amendments within stipulated timelines.
• Maintain an up-to-date regulatory status tracker for all registered products.
• Monitor and stay current with local and international regulatory guidelines legislation and industry best practices.
• Collect collate and evaluate scientific and regulatory data from internal and external sources.
• Draft clear and accurate regulatory justifications for new product registrations and renewals.
• Maintain proper regulatory documentation and records in line with ISO and company procedures.
• Review prepare and approve product labels package inserts and patient information leaflets in compliance with FDA requirements.
• Ensure labeling content is accurate clear and compliant with approved product information.
• Coordinate and support regulatory inspections conducted by FDA and other regulatory bodies.
• Prepare inspection readiness documentation and respond to inspection findings.
• Review company practices and recommend improvements to ensure ongoing regulatory compliance.
• Work closely with Quality Assurance (QA) and Quality Control (QC) teams to ensure compliance across product lifecycle.
• Support internal teams during product launches and post-marketing activities.
• Liaise with regulatory authorities and external stakeholders on regulatory matters.

Requirements

• Bachelors Degree in Pharmacy Chemistry Biochemistry Microbiology Life Sciences or a related field.
• A postgraduate qualification in Regulatory Affairs or Quality Management is an added advantage.
• Minimum of 24 years experience in regulatory affairs within the pharmaceutical or healthcare industry.
• Practical experience with FDA Ghana product registrations renewals and variations.
• Experience supporting regulatory inspections and audits.
• Strong knowledge of FDA Ghana regulatory requirements.
• Excellent documentation writing and analytical skills.
• High attention to detail and ability to meet strict regulatory deadlines.
• Proficiency in MS Office and regulatory documentation systems.
• Strong communication and stakeholder engagement skills.
• Ability to work independently and collaboratively across departments