Job Purpose:
We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for GHC/KSA.
Key Responsibilities:
- Compliance & Lifecycle Management: Prepare variation and requalification dossiers. Manage regulatory product maintenance across GHC/KSA.
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eCTD/CTD Sequence Review: Perform Level-1 review of CTD/eCTD sequences for assigned territories. Ensure submission quality and compliance with productivity and regulatory standards.
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Query Handling & Documentation: Draft and review regulatory authority responses. Ensure clarity, regulatory alignment, and timely submission.
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Functional File Preparation: Handle electronic publishing tasks including hyperlinking, bookmarking, redactions, and formatting. Ensure technical accuracy and reduce rework.
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Artwork & Labeling Review: Review annotated artwork and comparative labeling texts. Ensure accuracy, consistency, and regulatory compliance.
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Project Tracking & Documentation: Maintain trackers, task planners, product history logs, and query records. Ensure accurate and timely updates for internal and client reporting.
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Team Collaboration & Communication: Facilitate smooth communication with internal stakeholders and external clients. Ensure timely follow-ups, documentation clarity, and professional engagement.
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Educational Qualifications: B.Pharm / M.Pharm
Why Join Us
- Opportunity to contribute to key regulatory submissions
- Exposure to global health authority expectations
- Skill development and continuous learning environment
- Collaborative work culture