Regulatory Affairs Specialist
Department: Regulatory Affairs
Classification: Junior
General Summary
Establish and develop the regulatory process of EVA PHARMA in the market , and ensure adequate registration steps and procedures in new as well as established market .
Job Duties And Responsibilities Include But Are Not Limited To:
- 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 with Eva Pharma 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.
- Able to work with a team .
Job Requirements:
Education: Bachelor Degree in any pharmacy
Previous Experience: Experience in similar position.
Computer Skills: Very good in all Computer applications related to the work.
Other Skills Required: Good scientific search abilities.
Apply
