Job Description
Position: Senior Registration Officer Department: Registration Location: Jeddah, Saudi Arabia
Job Summary The Senior Registration Officer is responsible for preparing, reviewing, submitting, and following up on regulatory registration dossiers for pharmaceutical products across different regions. The role ensures compliance with applicable regulatory requirements and supports timely product registration, renewal, re-registration, and lifecycle management.
Key Responsibilities Regulatory Strategy & Compliance Participate in the development and implementation of regulatory strategies aligned with business and project requirements. Compile, analyze, and assess regulatory information and data. Identify critical regulatory factors and provide options and recommendations to decision-makers. Dossier Preparation & Submission Prepare and assemble regulatory dossiers in CTD and e CTD formats. Prepare files for:New product registration Re-registration Renewal Shelf-life extensions Company registration and re-registration Coordinate the acquisition, assessment, and compilation of all applicable regulatory data. Review registration files received from the manufacturing plant for accuracy, completeness, and compliance. Submit regulatory dossiers to relevant authorities in different regions, including SFDA and GCC Central Office. Regulatory Follow-up & Authority Liaison Follow up on registration applications with SFDA, GCC Central Office, and GCC countries to ensure timely approval. Act as a key point of contact between the company and regulatory authorities (SFDA, GCC Central, and GCC countries). Respond to authority queries in line with scientific and ethical standards and submit required amendments or variations. Post-Approval & Regulatory Maintenance Conduct regulatory monitoring of approved products and maintain updated regulatory files. Evaluate the impact of regulatory changes and post-approval variations and take appropriate regulatory actions. Support internal teams by providing regulatory guidance and ensuring ongoing compliance. Certificates & Documentation Obtain required regulatory documents, including:Certificates of Pharmaceutical Product (CPP) GMP Certificates Price Certificates Patency Certificates from KACSTCommunication & Support Provide regulatory advice and counseling to internal and external stakeholders. Communicate regulatory requirements, updates, and their application across the organization. Additional Duties Perform any other duties related to the role as assigned by the Direct Supervisor or their designee.
Job Requirements· Bachelor’s Degree in Pharmacy or Chemistry . Minimum of 4+ years of experience in KSA and the GCC region Preferably with a proven track record of successful SFDA approvals Experience in oncology and/or high-potent products is highly preferred
Skills & Competencies Strong pharmaceutical industry and regulatory knowledge Negotiation skills Analytical and problem-solving abilities Time management and organizational skills Strong interpersonal and communication skills Presentation skills High level of commitment and professionalism
Languages English – Fluent Arabic – Fluent