Pharmaceutical Documentation Officer(Regulatory) at Global Organics Limited

About the Role

Global Organics Limited is seeking a Pharmaceutical Documentation Officer for Regulatory purposes. The successful candidate will manage, create, review, and archive all quality and regulatory documents (including Certificates of Analysis, batch records, and process validation records) to support submissions for new product registrations and renewals. This role requires staying updated on regulatory laws, training staff, and preparing for audits while ensuring documents are precise, controlled, and submitted on time.

Key Responsibilities

• Compile and prepare pharmaceutical product dossiers in CTD 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, NAFDAC, and other local and international regulations
• Support internal audits and inspections 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 of 2 years' experience in pharmaceutical documentation
• Strong understanding of pharmaceutical regulations (GMP, GDP, local and global regulations)
• Exceptional attention to detail and organizational skills
• Strong written and verbal communication abilities
• Proficiency with IT systems
• Analytical thinking and project management skills

Preferred Experience

• Experience in CTD dossier preparation

Location

Lagos, Nigeria