Pharmaceutical Documentation Officer(Regulatory) at Global Organics Limited

We are looking for a Pharmaceutical Documentation Officer for Regulatory purpose. The prospective officer will manage, create, review, and archive all quality/regulatory documents (COAs, batch records, process validation records e.t.c) towards the submissions of required documents for new products registrations and renewals. The successful candidate will stay updated on laws, train staff, and prepare for audits, ensuring documents are precise, controlled, and submitted on time. 

Key Responsibilities

• Compile and prepare pharmaceutical products 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/international regulations.
• Support internal audits and inspections by regulatory bodies.
• Review/approve promotional materials, package inserts, and handle adverse event reporting. 

Essential Skills & Qualifications

• Bachelor's degree in a science field (Biochemistry, Chemistry, Microbiology).
• Minimum of 2 years’ experience in pharmaceutical documentation
• Experience in CTD dossier preparations is an added advantage   
• Strong understanding of pharmaceutical regulations (GMP, GDP, local/global rules).
• Exceptional attention to detail, organization, IT proficiency, written/verbal communication, analytical thinking, and project management.