Registration Officer

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 eCTD 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 KACST

Communication & 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