Regulatory Officer

Qualifications and Experience: (Education)

1. BSc in Pharmacy or a related life sciences field (e.g., Pharmaceutical Sciences, Chemistry, Biochemistry).

2. 3 to 5 years of experience in a regulatory affairs role within the pharmaceutical industry.

3. Hands-on experience with dossier preparation, product registration, and dealing with regulatory bodies (especially PPB) is essential.

4. Knowledge of GMP, GDP, and quality systems is a must.

Technical Skills:

1. Proficiency in Pharma ERP systems and Microsoft Office tools.

2 Excellent understanding of national and international regulatory requirements.

Soft Skills:

1. Strong communication and documentation skills.

2. Attention to detail, analytical mindset, and the ability to work under pressure.

3. Team player with good coordination and planning abilities.

Regulatory Submissions:

1. Prepare, compile, and review registration dossiers for submission to regulatory authorities (e.g., Pharmacy and Poisons Board - PPB), ensuring alignment with applicable guidelines and standards.

2. Follow up on submissions and manage the lifecycle of product registrations.

Sample Management:

1. Coordinate handling and dispatch of product samples for submission to authorities such as MEDS (Mission for Essential Drugs and Supplies).

2. Ensure documentation and timelines are adhered to.

Product Compliance:

1. Ensure that all products meet regulatory requirements with respect to content, labelling, packaging, and patient information (e.g., SPCs, PILs, packaging artwork).

2 Review and update documents periodically to maintain accuracy and compliance.

Vendor Qualification & GMP Compliance:

1. Support the Company Pharmacist in qualifying suppliers, vendors, and contractors.

2. Monitor and ensure compliance with Good Manufacturing Practices (GMP) and pharmaceutical quality standards.

Dossier Preparation for Drug Information:

Prepare drug information dossiers and data packages for submission to hospitals, tenders, institutions, and stakeholders.

Regulatory Query Management:

1. Prepare response documents for queries raised by regulatory authorities (e.g., PPB) within stipulated timelines.

2. Coordinate internal departments to collect supporting data and documentation.

Pharma ERP Software Handling:

Utilize and manage Pharma ERP systems for product tracking, documentation control, and regulatory data management.

Regulatory Intelligence:

1. Monitor and interpret changes in local and international regulatory legislation, guidelines, and customer expectations.

2.Advise the organization of relevant updates and recommend actions to maintain compliance.

Product Trials:

1. Plan and coordinate product trials or stability studies as necessary.

2. Collect, analyze, and interpret trial data in line with regulatory expectations.

Other Duties:

Undertake additional responsibilities or projects as assigned by the immediate supervisor or GM –Quality.