Regulatory Affairs (....
Regulatory Affairs ( Section Head )
Posted on :
27-11-2020
Employer Active
1 Vacancy
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Job Description
Req ID : 412635
- Responsible for preparation of Registration dossiers of all new products and Re-registered products.
- Responsible for preparation and submission of Analytical dossiers to NODCAR ( National Organization for Drug control and Research )
- Follow up all steps of registration in MOH (Ministry of Health) including Stability Study, Bioequivalence Study, Inserts, Packs and Analysis.
- Follow up any change needed in any product such as change in pack, formula or name.
- Establish and maintain good relationship with the internal and external stakeholders.
- Coordinate with the R&D, Q.C, Production, Marketing team members regarding the different registration issues.
- Ensure all registration activities are in compliance the company and National laws & regulations.
- Ensures confidentiality in respect of registration files contents.
- Carefully review compiled files to ensure that content, quality, accuracy and format of submission Comply with applicable regulations of the market.
- Develop and maintain registration track record for the market
Employment Type
Full Time
Department / Functional Area
Key Skills
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