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Job Description
- Prepare the registration application files in accordance with the local regulations to present to EDA
- Collaborate with the planning department regarding all new and updated products while adhering to regulatory Lead-time.
- Completing all registration requirements for all shipments at EDA.
- Preparation of MOH annual importation Plan
- preparing regulatory registration, notification, and pre-market submission requirements, including the necessary regulatory documents.
- Understand the business environment and relate extensive knowledge of internal and external activities to trends; determine trade issues to anticipate regulatory obstacles.
- Maintain regulatory data in electronic systems.
- Assist in SOP development and review.
- Maintain current registrations by preparing documentation required and submitting documentation on schedule as directed.
- Ensure that quality standards, and submissions plans are met within the targeted timelines.
- ACI shipments processing.
Job Requirements
- Bachelor’s degree in pharmacy, Science, or vet medicine.
- Knowledge of EDA regulatory affairs is a must.
- Experience mainly in Diagnostic and medical devices.
- Supply chain background is a plus
- Good knowledge of preparation of registration files.
- Excellent command of English.
- 2 to 3 years’ experience.
