Regulatory Affairs Executive

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