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Job Description
- Keep abreast of current regulatory knowledge, trends, developments, legislation, and guidelines.
- Ensure that the company strictly follows government rules and regulations.
- Prepare regulatory documentation required for registration of the company’s new products and maintenance of existing ones.
- Prepare regulatory documentation required for submissions of products’ variations along their lifecycle.
- Interface with other departments to provide regulatory advice and obtain the necessary documents in accordance with regulatory authorities’ guidelines.
- Submit regulatory documentation to regulatory authorities within the specified timeframe by negotiating and communicating effectively to obtain timely product approvals.
- Maintain regulatory files in a format consistent with requirements.
- Document, track and store regulatory documents properly.
- Act as regulatory representative in different internal committees.
- Create regulatory Standard Operating Procedures, as necessary.
- Implement and ensure sustainability of each SOP per function.
Job Requirements
- Bachelor Degree in Pharmaceutical Sciences.
- 1-3 years experience in a similar position
- Very Good command of English language written & spoken
- Proficiency in MS Office: Word, Excel, PowerPoint
