Regulatory Affairs Officer

The Regulatory Affairs Officer provides high-level strategic oversight, expert technical guidance, and regulatory leadership to ensure full compliance with Good Manufacturing Practice (GMP), national regulations (EFDA), and international standards (WHO Prequalification) across the entire facility lifecycle. The role spans conceptual design, engineering, construction, commissioning, qualification, validation, licensing, and operational readiness for the integrated Vaccine, Pharmaceutical, and Diagnostic Manufacturing Plant.

• Planning & Design Integration: Embed international GMP principles into architectural layouts, engineering designs, and process flows; review cleanroom classifications, HVAC systems, critical utilities (PW/WFI/pure steam), and equipment compliance.
• Construction & Operational GMP Management: Develop and enforce protocols for personnel gowning (PPE), access zoning, clean/non-clean segregation, and contamination control during construction and operational phases.
• Documentation, Validation & Regulatory Affairs: Oversee the generation and approval of GMP documentation (SOPs, VMPs, protocols); coordinate facility licensing applications and product registration dossiers with EFDA; support WHO PQ and international inspections.
• Training, Auditing & Technical Leadership: Train engineering, construction, and operational staff on GMP and contamination control; participate in internal QA audits, gap assessments, deviation investigations, and CAPA programs.
• Reporting & Governance: Submit regular work plans and performance reports to the CEO, including regulatory risk assessments and inspection readiness status.
• Authority & Accountability: Exercise authority to evaluate and address contractor/vendor non-compliance with GMP standards; ensure adherence to occupational health, safety, and environmental (HSE) requirements.

• Educational Background: Master’s or Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Engineering, or Pharmaceutical Biotechnology.
• Work Experience: Minimum of 10 years of experience with a Master’s degree, or 12 years with a Bachelor’s degree, in pharmaceutical or biopharmaceutical manufacturing within Regulatory Affairs, Manufacturing, or Quality Assurance (QA). This must include at least 5 years in a supervisory or managerial role.

• In-depth knowledge of GMP requirements for vaccines, pharmaceuticals, and diagnostics.
• Strong understanding of cleanroom design, HVAC, contamination control, utilities, and validation/qualification requirements.
• Experience in greenfield projects, commissioning, qualification, and validation.
• Excellent technical, written, and verbal communication skills in English.
• Core competencies: Ability to review architectural/engineering designs for QA/GMP compliance, strong validation and vendor-assessment capabilities, analytical problem-solving, leadership, professional integrity, and cross-functional coordination.
• Core Skill Tags: Strong financial analysis, Quality assurance and compliance focus.