Job Details

Hiring for a reputed pharmaceutical manufacturing company based in UAE

Responsibilities:

•⁠ ⁠Analyze broad-scope implications of changing regulations and guidance

•⁠ ⁠Knowledge of CTD Dossier preparation

•⁠ ⁠Registration of required classified products

•⁠ ⁠Knowledge of MOH UAE system

•⁠ ⁠Maintenance and implementation of pharmacovigilance system

•⁠ ⁠Assist as needed in providing necessary documentation or information to support import and export of regulated products

•⁠ ⁠Monitor the impact of changing regulations on submission strategies and update internal stakeholders

•⁠ ⁠Assist in regulatory due diligence for potential and new acquisitions. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

•⁠ ⁠Represent Company to authorities in the Ministry of Health whenever required

•⁠ ⁠Licensing from MOH for advertisement for suppliers

•⁠ ⁠Represent Company wherever required

Requirements:

•⁠ ⁠Minimum 3-4 years of experience in Regulatory but not limited to

•⁠ ⁠Education - B. Pharm/ D. Pharm

•⁠ Knowledge of CT Dossier preparation and submission in MOH UAE system

•⁠ Knowledge of MOH, UAE Regulations, decisions & decrees

•⁠ Maintenance and implementation of Pharmacovigilance system

•⁠ Fluent in Arabic Language