Documentation Officer at Global Organics Limited

We are seeking a highly organized, detail-oriented, and responsible Documentation Officer to join our team. The successful candidate will be responsible for maintaining accurate regulatory and product documentation, supporting dossier compilation, document tracking, and ensuring that required records are properly controlled and readily available in compliance with applicable regulatory and Good Manufacturing Practice (GMP) requirements.

KEY RESPONSIBILITIES

• Assist in the compilation, review, maintenance, and updating of CTD (Common Technical Document) dossiers.
• Gather, organize, file, and archive addendum documents and supporting documents for CTD dossiers.
• Monitor, track, and upload regulatory and product information on relevant platforms and portals, including NAPAMS, DMS, GS1, and other applicable regulatory systems.
• Maintain proper documentation and records relating to Adverse Drug Reactions (ADRs) and pharmacovigilance activities.
• Support the maintenance of product safety profiles and monitoring of emerging safety concerns.
• Assist with the compilation and maintenance of product-related regulatory documentation.
• Ensure documents are properly indexed, controlled, updated, and archived in accordance with company procedures.
• Maintain accurate records of regulatory submissions, approvals, renewals, variations, and other regulatory activities.
• Track submission deadlines and follow up on outstanding regulatory documentation.
• Assist in preparing documents required for product registration, renewal, variation, and regulatory correspondence.
• Ensure the integrity, confidentiality, traceability, and accessibility of regulatory documents.
• Liaise with Regulatory Affairs, Quality Assurance, Pharmacovigilance, Production, and other relevant departments to obtain required documentation.
• Support internal and regulatory audits by retrieving and presenting required documentation.
• Perform other documentation and regulatory support duties as assigned by Management.

QUALIFICATIONS & EXPERIENCE

• Bachelor's Degree in Pharmacy, Pharmacology, Biology, Epidemiology, Biological Sciences, or other relevant fields.
• Minimum of 2 years’ relevant experience, preferably in pharmaceutical manufacturing Company.
• Knowledge of CTD dossier compilation and regulatory documentation will be an added advantage.
• Familiarity with NAPAMS, DMS, GS1, and other regulatory/product information platforms is an advantage.
• Good knowledge of Microsoft Office, particularly Microsoft Word and Excel.
• Strong documentation, organizational, analytical, and record-keeping skills.
• Excellent attention to detail and ability to maintain accuracy when handling large volumes of documentation.
• Good written and verbal communication skills.