
Pharmaceutical Registration Expert
2 days ago
Regulatory Compliance Specialist
Job Overview:We are seeking a skilled Regulatory Compliance Specialist to support our expansion of regulatory services. The ideal candidate will have expertise in drug registration, dossier preparation, and compliance strategies for local and global markets.
Main Responsibilities:- Prepare/review Clinical Trial Dossiers (Modules 1–5)
- Navigate the process of DRAP licensing and regulatory submissions
- Provide advice on local and international compliance strategies (GMP/ICH/EMA/US FDA preferred)
- Offer documentation and audit-readiness support
- At least 5 years of experience in regulatory affairs within the pharmaceutical industry
- Strong understanding of DRAP, ICH, and preferably US FDA / ECU / GCC regulations
- Proficiency in documentation and regulatory frameworks
- Proactive, detail-oriented, and comfortable working with lean teams
Benefits of the Role:
- Empower innovative formulations with regulatory confidence
- Collaborate to drive excellence in drug development and manufacturing
About the Position:
- Regulatory expertise is essential for success in this role
- A strong understanding of regulatory frameworks is necessary
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