Pharmaceutical Documentation Officer(Regulatory) at Global Organics Limited

About the Role

Global Organics Limited is seeking a Pharmaceutical Documentation Officer to manage regulatory and quality documentation. The successful candidate will create, review, and archive all quality and regulatory documents (including Certificates of Analysis, batch records, and process validation records) to support new product registrations and renewals. You will stay updated on regulatory requirements, train staff on documentation standards, and prepare the organization for audits, ensuring all documents are precise, controlled, and submitted on time.

Key Responsibilities

• Compile and prepare pharmaceutical product dossiers in CTD (Common Technical Document) format
• Interface with regulatory authorities as directed by the regulatory manager
• Prepare, compile, and submit technical files, applications, renewals, and variations for product registration and maintenance
• Ensure all documentation adheres to GMP (Good Manufacturing Practice), NAFDAC, and other local and international regulations
• Support internal audits and inspections conducted by regulatory bodies
• Review and approve promotional materials and package inserts
• Handle adverse event reporting

Essential Qualifications

• Bachelor's degree in a science field (Biochemistry, Chemistry, or Microbiology)
• Minimum 2 years' experience in pharmaceutical documentation
• Strong understanding of pharmaceutical regulations (GMP, GDP, and local/global regulatory requirements)

Required Skills

• Experience in CTD dossier preparation (advantageous)
• Exceptional attention to detail
• Strong organizational skills
• IT proficiency
• Written and verbal communication skills
• Analytical thinking
• Project management abilities

Location

Lagos, Nigeria