A. Job Summary To support the Regulatory Affairs Department in preparing, submitting, and maintaining product registrations and variations with health authorities, ensuring compliance with applicable regulations and company policies. The role will assist in the preparation of regulatory dossiers, monitoring regulatory changes, and support product lifecycle management. B. Key Responsibilities Core Area: 1. Product Registration & Licensing • Prepare, compile, and submit dossiers for new product registrations, renewals, and variations to health authorities. • Ensure timely approvals for company products. 2. Regulatory Compliance • Ensure all company products, processes, labeling, and promotional materials comply with local and international regulatory requirements. • Monitor regulatory updates and guidelines, and communicate changes to relevant departments. 3. Documentation & Dossier Management • Maintain up-to-date records of product registrations, licenses, and approvals • Maintain regulatory files and databases in the required format. • Ensure availability and accuracy of documents such as labels, and artwork. 4. Liaison with Health Authorities • Act as a point of contact between the company and regulatory bodies. • Respond to authority queries and provide clarifications in a timely manner. 5. Product Lifecycle Management • Support post-marketing regulatory activities, including renewals, variations, and safety updates. • Ensure continuous compliance of marketed products with current regulations. 6. Cross-functional Collaboration • Work closely with R&D, QA, QC, Production, and Marketing teams to gather data and documents required for submissions. • Provide regulatory input during product development and commercialization. 7. Audit & Inspection Readiness • Support the preparation of regulatory documentation for audits and inspections. • Participate in internal and external audits. • Ensure regulatory documents and systems are inspection-ready. 8. Training & Awareness • Provide training to internal teams on regulatory requirements. • Build awareness of compliance standards across the organization 9. Other Responsibilities • Carry out any additional tasks assigned by the head of department and direct supervisor. C. Job Specifications Education - Bachelor’s degree in Pharmacy (B. Pharm) or equivalent. Experience - 0–2 years of experience in Regulatory Affairs or related pharmaceutical functions - Basic understanding of pharmaceutical regulations, guidelines, and product registration processes in the GCC/Middle East region is an advantage.. - Knowledge of GMP, regulatory requirements and quality systems. Functional Competencies - Knowledge of regulatory guidelines (local & international). - Basic understanding of dossier compilation and submission. - Familiarity with pharmacovigilance requirements. - Ability to review and assess regulatory documents and artwork. - Proficiency in MS Office and regulatory databases Core Competencies - Attention to detail and accuracy. - Strong organizational and time-management skills. - Team player with ability to collaborate across departments. - Analytical and problem-solving mindset. - Continuous Learning – Keeps updated with GMP guidelines and local and internal regulations and practices
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